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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 23 - 23
10 May 2024
Leary J Lynskey T Muller A
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Objective

Carpal tunnel release surgery is a commonly performed procedure for alleviating symptoms of median nerve compression and restoring hand function. With pressure on theatre time these procedures are now commonly performed in a step-down out-patient facility under local anaesthetic. The choice of suture for skin closure in this procedure can impact the quality of wound healing, patient outcomes and the follow-up required however the question of the best type of suture remains unanswered. The purpose of this study was to compare the outcomes of absorbable and non-absorbable sutures using a randomised control trial design.

Methods

Eighty patients diagnosed with bilateral carpal tunnel syndrome were enrolled and underwent outpatient carpal tunnel release surgery under local anaesthetic in a staged fashion. Random number generation was used to assign each hand to receive interrupted nylon or Vicryl Rapide sutures. Pre-operative data collection included patient demographics, ASA, inflammatory conditions, smoking status as well as a Boston Carpal Tunnel Questionnaire (BCTQ) for each hand. Patients were followed up at 2 and 6 weeks after each operation and the BCTQ was repeated along with the Patient and Observer Scar Assessment Scale and the VAS score for wound discomfort. This study has approval from the DHB ethics committee, Local Iwi, HDC and ANZ Clinical Trials:ACTRN12623000100695.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 53 - 53
7 Aug 2023
Arthur J Makovicka J Bingham J Spangehl M Clarke H Dossett HG
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Abstract

Introduction

The optimal alignment technique for total knee replacement (TKR) remains controversial. We previously reported six-month and two-year results of a randomized controlled trial comparing kinematically (KA) versus mechanically (MA) aligned TKR. In the present study, we report 12-year results from this trial.

Methods

The original cohort included 88 TKRs (44 KA using Shape Match patient-specific guides and 44 MA using conventional instrumentation), performed from 2008 to 2009. After IRB approval, the health record of the original 88 patients were queried. Revisions, re-operations, and complications were recorded. The non-deceased patients were contacted via phone. Reoperation and complications were documented via the patient's history. Further, a battery of patient-reported outcome measures (including patient satisfaction, WOMAC, Oxford, KOOS Jr, Forgotten Joint Score, and M-SANE) were obtained.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 36 - 36
7 Aug 2023
Matthews S Acton D Tucker A Graham J
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Abstract

Introduction

The Syn-VAR RCT is the first of its kind comparing hamstrings autograft v synthetic neoligament for MPFL reconstruction.

Our aim is to evaluate short and long term patient related outcomes measures (PROMs) following synthetic / autologous MPFL reconstruction in a heterogenous cohort of patients with recurrent patellar instability.

Method

20 patients meeting inclusion criteria were recruited and randomised. Standardised surgery was performed by a single surgeon in Altnagelvin Hospital with data collected over 3 years from 2016. Kujala score was the primary outcome measure with data captured preoperatively and 12 weeks/2 years postoperatively. Secondary outcomes included four other validated scores and complications including Norwich Patellar Instability, Lysholm, IKDC and Banff


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 2 - 2
1 Dec 2022
Schneider P Bergeron S Liew A Kreder H Berry, G
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Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes.

Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model.

A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group.

This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 26 - 26
1 Dec 2022
Lapner P Pollock J Hodgdon T Zhang T McIlquham K Coupal S Bouliane M McRae S Dubberley J Berdusco R Stranges G Marsh J Old J MacDonald PB
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Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Our secondary objectives were to compare disease-specific quality of life and patient reported outcomes as measured by the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Constant score between groups.

Patients undergoing arthroscopic rotator cuff repair at three sites were randomized to receive either bone channeling augmentation or standard repair. Healing rates were determined by ultrasound at 6 and 24 months post operatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12 and 24 months post operatively.

One hundred sixty-eight patients were recruited and randomized between 2013 to 2018. Statistically significant improvements occurred in both groups from pre-operative to all time points in all clinical outcome scores (p < 0 .0001). Intention to treat analysis revealed no statistical differences in healing rates between the two interventions at 24 months post-operative. No differences were observed in WORC, ASES or Constant scores at any time-point.

This trial did not demonstrate superiority of intra-operative bone channeling in rotator cuff repair surgery at 24 months post-operative. Healing rates and patient-reported function and quality of life measures were similar between groups.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 77 - 77
1 Dec 2022
Schneider P Bergeron S Liew A Kreder H Berry G
Full Access

Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes.

Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model.

A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group.

This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 111 - 111
10 Feb 2023
Sonntag J Landale K Brorson S A. Harris I
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The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized controlled trial (RCT) and to study patterns of change between subspecialties and nationalities.

Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year.

Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, 6 of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle.

The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 94 - 94
4 Apr 2023
Çil E Subaşı F Şaylı U
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Plantar fasciitis (PF) is one of the widespread conditions causing hindfoot pain. The most common presenting symptoms are functional limitation and pain (first step and activity) on plantar surface of the foot. The non-operative treatments provide complete resolution of pain in 90% of patients, but functional limitation still remains as a risk factor for recurrency of PF. Although the number of non-operative treatment options showing efficacy on pain and functional limitation are excessive, the evidences are limited for functional limitation. Additionally, Mulligan mobilization with movement (MMWM) in Chronic Plantar Fasciitis has been poorly studied in the literature. According to these findings, the study was aimed to determine effectiveness of Mulligan mobilization with movement on Chronic Plantar Fasciitis.

A total of 25 patients (40 feet) with chronic PF were included in the study. The patients were randomly divided into Mulligan concept rehabilitation group (PF-M, n=20 feet) and Home Rehabilitation group (PF-H, n=20 feet). (MMWM), Foot and ankle exercises program were applied to PF-M, twice a week totally 8 week (16 sessions) and foot- ankle exercises as a home program were given for PF-H, 8 weeks. The range of motion (ROM) for dorsiflexion and plantar flexion was measured by using a manual goniometer. Pain, disability and activity restriction were assessed by Foot Function Index (FFI) . The first step morning pain was evaluated by Visual Analogue Scale (VAS) and Kinesiophobia was also reported by using Tampa Scale (TSK). Patients were evaluated at baseline and 8 weeks.

FFI, VAS, TSK, ROM values improved in all groups (intragroup variability) at 8th week (P < .05). The other result indicated that ROM values for DF and PF and TSK scores in PF-M had more significant improvement than PF-H (p<.05).

To the best of our knowledge this is the first randomised controlled trial for investigating Mulligan Concept efficiancy on chronic PF. Both Mulligan mobilization with movement (MMWM) and exercise protocols are effective for chronic PF. Furthermore, The Mulligan concept seems more effective treatment option in reducing kinesiophobia and improving functional capacity.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 44 - 44
1 Dec 2022
Turgeon T Bohm E Gascoyne T Hedden D Burnell C
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This study used model-based radiostereometric analysis (MBRSA) to compare migration of a recently introduced cementless hip stem to an established hip stem of similar design. Novel design features of the newer hip stem included a greater thickness of hydroxyapatite coating and a blended compaction extraction femoral broach.

Fifty-seven patients requiring primary total hip arthroplasty (THA) were enrolled at a single centre. Patients were randomized to receive either an Avenir collarless stem and Trilogy IT cup (ZimmerBiomet) or a Corail collarless stem and Pinnacle cup (DePuy Synthes) via a posterior or lateral approach. Both stems are broach-only femoral bone preparation. RSA beads (Halifax Biomedical) were inserted into the proximal femur during surgery. Patients underwent supine RSA imaging a 6 weeks (baseline), 6, 12, and 24 months following surgery. The primary study outcome was total subsidence of the hip stem from baseline to 24 months as well as progression of subsidence between 12 and 24 months. These values were compared against published migration thresholds for well-performing hip stems (0.5mm). The detection limit, or precision, of MBRSA was calculated based on duplicate examinations taken at baseline. Patient reported outcome measures were collected throughout the study and included the Oxford-12 Hip Score (OHS), EuroQoL EQ-5D-5L, Hip Osteoarthritis Score (HOOS) as well as visual analogue scales (VAS) for thigh pain and satisfaction. Analysis comprised of paired and unpaired t-tests with significance set at p≤0.05.

Forty-eight patients (30 males) were included for analysis; 7 patients received a non-study hip stem intra-operatively, 1 patient suffered a traumatic dislocation within three weeks of surgery, and 1 patient died within 12 months post-surgery. RSA data was obtained for 45 patients as three patients did not receive RSA beads intra-operatively. Our patient cohort had a mean age of 65.9 years (±;7.2) at the time of surgery and body mass index of 30.5 kg/m2 (±;5.2). No statistical difference in total stem migration was found between the Avenir and Corail stems at 12 months (p=0.045, 95%CI: −0.046 to 0.088) and 24 months (p=0.936, 95% CI: −0.098 to 0.090). Progression of subsidence from 12-24 months was 0.011mm and 0.034mm for the Avenir and Corail groups which were not statistically different (p=0.163, 95%CI: −0.100 to 0.008) between groups and significantly less than the 0.5mm threshold (pNo statistically significant differences existed between study groups for any pre-operative function scores (p>0.05). All patients showed significant functional improvement from pre- to post-surgery and no outcome measures were different between study groups with exception of EQ-5D-5L health visual analogue scale at 12 months which showed marginally superior (p=0.036) scores in the Avenir group. This study was not powered to detect differences in clinical outcomes.

This study has demonstrated no statistical difference in subsidence or patient-reported outcomes between the Corail hip stem and the more recently introduced Avenir hip stem. This result is predictable as both stems are of a triple-tapered design, are coated with hydroxyapatite, and utilize a broach-only bone preparation technique. Both stem designs demonstrate migration below 0.5mm suggesting both are low-risk for aseptic loosening in the long-term.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 6 - 6
1 Jul 2022
Hamilton T Knight R Stokes J Rombach I Cooper C Davies L Dutton S Barker K Cook J Lamb S Murray D Poulton L Wang A Strickland L Duren BV Leal J Beard D Pandit H
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Abstract

Introduction

This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement.

Methodology

533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 65 - 65
1 Dec 2022
Gazendam A Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery.

The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups.

As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X).

The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 29 - 29
19 Aug 2024
Kayani B Konan S Tahmassebi J Giebaly D Haddad FS
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The direct superior approach (DSA) is a modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoined tendon during total hip arthroplasty (THA). The objective of this study was to compare postoperative pain, early functional rehabilitation, functional outcomes, implant positioning, implant migration, and complications in patients undergoing the DSA versus PA for THA.

This study included 80 patients with symptomatic hip arthritis undergoing primary THA. Patients were prospectively randomised to receive either the DSA or PA for THA, surgery was undertaken using identical implant designs in both groups, and all patients received a standardized postoperative rehabilitation programme. Predefined study outcomes were recorded by blinded observers at regular intervals for two-years after THA. Radiosteriometric analysis (RSA) was used to assess implant migration.

There were no statistical differences between the DSA and PA in postoperative pain scores (p=0.312), opiate analgesia consumption (p=0.067), and time to hospital discharge (p=0.416). At two years follow-up, both groups had comparable Oxford hip scores (p=0.476); Harris hip scores (p=0.293); Hip disability and osteoarthritis outcome scores (p=0.543); University of California at Los Angeles scores (p=0.609); Western Ontario and McMaster Universities Arthritis Index (p=0.833); and European Quality of Life questionnaire with 5 dimensions scores (p=0.418). Radiographic analysis revealed no difference between the two treatment groups for overall accuracy of acetabular cup positioning (p=0.687) and femoral stem alignment (p=0.564). RSA revealed no difference in femoral component migration (p=0.145) between the groups at two years follow-up.

There were no differences between patients undergoing the DSA versus PA for THA with respect to postoperative pain scores, functional rehabilitation, patient-reported outcome measurements, accuracy of implant positioning, and implant migration at two years follow-up. Both treatment groups had excellent outcomes that remained comparable at all follow-up intervals.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 34 - 34
7 Jun 2023
Board T Powell R Davies A Coffey T Wylde V Taylor T Hickey H Gornall M Jackson R Dalal G Eden M Wilson M Divecha H
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Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021).

Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings.

The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training.

We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 86 - 86
24 Nov 2023
Veerman K Telgt D Rijnen W Goosen J
Full Access

Aim

In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty.

Method

This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 10 - 10
1 Dec 2022
Behman A Bradley C Maddock C Sharma S Kelley S
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There is no consensus regarding the optimum frequency of ultrasound for monitoring the response to Pavlik harness (PH) treatment in developmental dysplasia of hip (DDH). The purpose of our study was to determine if a limited-frequency hip ultrasound (USS) assessment in children undergoing PH treatment for DDH had an adverse effect on treatment outcomes when compared to traditional comprehensive ultrasound monitoring.

This study was a single-center non-inferiority randomized controlled trial. Children aged less than six months of age with dislocated, dislocatable and stable dysplastic hips undergoing a standardized treatment program with a PH were randomized, once stability had been achieved, to our current standard USS monitoring protocol (every clinic visit) or to a limited-frequency ultrasound protocol (USS only until hip stability and then end of treatment). Groups were compared based on alpha angle at the end of treatment, acetabular indices (AI) and IHDI grade on follow up radiographs at one-year post harness and complication rates. The premise was that if there were no differences in these outcomes, either protocol could be deemed safe and effective.

One hundred patients were recruited to the study; after exclusions, 42 patients completed the standard protocol (SP) and 36 completed the limited protocol (LP). There was no significant difference between the mean age between both groups at follow up x-ray (SP: 17.8 months; LP: 16.6 months; p=0.26). There was no difference between the groups in mean alpha angle at the end of treatment (SP: 69°; LP: 68.1°: p=0.25). There was no significant difference in the mean right AI at follow up (SP: 23.1°; LP: 22.0°; p=0.26), nor on the left (SP:23.3°; LP 22.8°; p=0.59). All hips in both groups were IHDI grade 1 at follow up. The only complication was one femoral nerve palsy in the SP group. In addition, the LP group underwent a 60% reduction in USS use once stable.

We found that once dysplastic or dislocated hips were reduced and stable on USS, a limited- frequency ultrasound protocol was not associated with an inferior complication or radiographic outcome profile compared to a standardized PH treatment pathway. Our study supports reducing the frequency of ultrasound assessment during PH treatment of hip dysplasia. Minimizing the need for expensive, time-consuming and in-person health care interventions is critical to reducing health care costs, improving patient experience and assists the move to remote care. Removing the need for USS assessment at every PH check will expand care to centers where USS is not routinely available and will facilitate the establishment of virtual care clinics where clinical examination may be performed remotely.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 27 - 27
1 Dec 2022
Suter T Old J McRae S Woodmass J Marsh J Dubberley J MacDonald PB
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Adequate visual clarity is paramount to performing arthroscopic shoulder surgery safely, efficiently, and effectively. The addition of epinephrine in irrigation fluid, and the intravenous or local administration of tranexamic acid (TXA) have independently been reported to decrease bleeding thereby improving the surgeon's visualization during arthroscopic shoulder procedures. No study has compared the effect of systemic administered TXA, epinephrine added in the irrigation fluid or the combination of both TXA and epinephrine on visual clarity during shoulder arthroscopy with a placebo group. The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine delivered by a pressure-controlled pump in improving arthroscopic shoulder visualization during arthroscopic procedures and whether using both TXA and epinephrine together has an additive effect in improving visualization.

The design of the study was a double-blinded, randomized controlled trial with four 1:1:1:1 parallel groups conducted at one center. Patients aged ≥18 years undergoing arthroscopic shoulder procedures including rotator cuff repair, arthroscopic biceps tenotomy/tenodesis, distal clavicle excision, subacromial decompression and labral repair by five fellowship-trained upper extremity surgeons were randomized into one of four arms: Pressure pump-controlled regular saline irrigation fluid (control), epinephrine (1ml of 1:1000) mixed in irrigation fluid (EPI), 1g intravenous TXA (TXA), and epinephrine and TXA (EPI/TXA). Visualization was rated on a 4-point Likert scale every 15 minutes with 0 indicating ‘poor’ quality and 3 indicating ‘excellent’ quality. The primary outcome measure was the unweighted mean of these ratings. Secondary outcomes included mean arterial blood pressure (MAP), surgery duration, surgery complexity, and adverse events within the first postoperative week.

One hundred and twenty-eight participants with a mean age (± SD) of 56 (± 11) years were randomized. Mean visualization quality for the control, TXA, EPI, and EPI/TXA groups were 2.1 (±0.40), 2.1 (±0.52), 2.6 (±0.37), 2.6 (±0.35), respectively. In a regression model with visual quality as the dependent variable, the presence/absence of EPI was the most significant predictor of visualization quality (R=0.525; p < 0 .001). TXA presence/absence had no effect, and there was no interaction between TXA and EPI. The addition of MAP and surgery duration strengthened the model (R=0.529; p < 0 .001). Increased MAP and surgery duration were both associated with decreased visualization quality. When surgery duration was controlled, surgery complexity was not a significant predictor of visualization quality. No adverse events were recorded in any of the groups.

Intravenous administration of TXA is not an effective alternative to epinephrine in the irrigation fluid to improve visualization during routine arthroscopic shoulder surgeries although its application is safe. There is no additional improvement in visualization when TXA is used in combination with epinephrine beyond the effect of epinephrine alone.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 96 - 96
10 Feb 2023
Blundell J Hope M
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Patients awaiting resolution of swelling and oedema prior to ankle surgery can represent a significant burden on hospital beds. Our study assessed whether external pneumatic intermittent compression (EPIC) can reduce delays to surgery.

Our prospective randomised controlled trial (n= 20) compared outcomes of patients treated with EPIC vs control group managed with ice and elevation. Included were patients aged <18 years with isolated closed ankle fractures admitted for management of swelling prior to surgery. Excluded were open fractures, injuries to contralateral leg, diabetes, absent pulses, peripheral vascular disease, inability to consent, no requirement for admission. Eligible patients were randomised to active or control arms. All patients were managed initially with reduction and back slab application. Patients in active arm fitted with EPIC (Hydroven 3000) device over the back slab. Assessment by treating team determined the time at which patient is assessed ready for surgery.

Patients in the treatment arm were assessed as ready for surgery sooner, (123 hrs vs 168hrs, T score = 1.925, P 0.035) and had a shorter time to surgery (167 hrs vs 216 hrs, T score = 1.748, P 0.047) Length of stay was reduced bud did not reach statistical significance. (259 hrs vs 269 hrs, T score 0.229, P 0.41)

Our results showed a statistically and clinically significant reduction in time that patients were assessed ready for surgery and time to surgery in the treatment cohort. We conclude that although further data is needed to achieve an adequately powered study and assess the safety profile of the EPIC, incorporation of EPIC into routine clinical practice has the potential for significant cost savings.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 5 - 5
1 Dec 2022
McRae S Suter T Old J Zhang Y Woodmass J Marsh J Dubberley J MacDonald P
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Adequate visual clarity is paramount to performing arthroscopic shoulder surgery safely, efficiently, and effectively. The addition of epinephrine in irrigation fluid, and the intravenous or local administration of tranexamic acid (TXA) have independently been reported to decrease bleeding thereby improving the surgeon's visualization during arthroscopic shoulder procedures. No study has compared the effect of systemic administered TXA, epinephrine added in the irrigation fluid or the combination of both TXA and epinephrine on visual clarity during shoulder arthroscopy with a placebo group. The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine delivered by a pressure-controlled pump in improving arthroscopic shoulder visualization during arthroscopic procedures and whether using both TXA and epinephrine together has an additive effect in improving visualization.

The design of the study was a double-blinded, randomized controlled trial with four 1:1:1:1 parallel groups conducted at one center. Patients aged ≥18 years undergoing arthroscopic shoulder procedures including rotator cuff repair, arthroscopic biceps tenotomy/tenodesis, distal clavicle excision, subacromial decompression and labral repair by five fellowship-trained upper extremity surgeons were randomized into one of four arms: Pressure pump-controlled regular saline irrigation fluid (control), epinephrine (1ml of 1:1000) mixed in irrigation fluid (EPI), 1g intravenous TXA (TXA), and epinephrine and TXA (EPI/TXA). Visualization was rated on a 4-point Likert scale every 15 minutes with 0 indicating ‘poor’ quality and 3 indicating ‘excellent’ quality. The primary outcome measure was the unweighted mean of these ratings. Secondary outcomes included mean arterial blood pressure (MAP), surgery duration, surgery complexity, and adverse events within the first postoperative week.

One hundred and twenty-eight participants with a mean age (± SD) of 56 (± 11) years were randomized. Mean visualization quality for the control, TXA, EPI, and EPI/TXA groups were 2.1 (±0.40), 2.1 (±0.52), 2.6 (±0.37), 2.6 (±0.35), respectively. In a regression model with visual quality as the dependent variable, the presence/absence of EPI was the most significant predictor of visualization quality (R=0.525; p < 0 .001). TXA presence/absence had no effect, and there was no interaction between TXA and EPI. The addition of MAP and surgery duration strengthened the model (R=0.529; p < 0 .001). Increased MAP and surgery duration were both associated with decreased visualization quality. When surgery duration was controlled, surgery complexity was not a significant predictor of visualization quality. No adverse events were recorded in any of the groups.

Intravenous administration of TXA is not an effective alternative to epinephrine in the irrigation fluid to improve visualization during routine arthroscopic shoulder surgeries although its application is safe. There is no additional improvement in visualization when TXA is used in combination with epinephrine beyond the effect of epinephrine alone.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 13 - 13
19 Aug 2024
DeBenedetti A Weintraub MT Valle CJD Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An a priori power analysis determined that 40 patients (20 per cohort) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power.

Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively.

There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 8 - 8
7 Aug 2023
Kaka A Shah A Yunus A Patel A Patel A
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Abstract

Introduction

Challenges in surgical training have led to the exploration of technologies such as augmented reality (AR), which present novel approaches to teaching orthopaedic procedures to medical students. The aim of this double-blinded randomised-controlled trial was to compare the validity and training effect of AR to traditional teaching on medical students’ understanding of total knee arthroplasty (TKA).

Methodology

Twenty medical students from 7 UK universities were randomised equally to either intervention or control groups. The control received a consultant-led teaching session and the intervention received training via Microsoft HoloLens, where surgeons were able to project virtual information over physical objects. Participants completed written knowledge and practical exams which were assessed by 2 orthopaedic consultants. Training superiority was established via 4 quantitative outcome measures: OSATS scores, a checklist of TKA-specific steps, procedural time, and written exam scores. Qualitative feedback was evaluated using a 5-point Likert scale.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 14 - 14
23 Jun 2023
Hooper G Thompson D Frampton C Lash N Sharr J Fulkner D Gilchrist N
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Femoral stem design affects periprosthetic bone mineral density (BMD), which may impact long term survival of cementless implants in total hip arthroplasty (THA). The aim of this study was to examine proximal femoral BMD in three morphologically different uncemented femoral stems designs to investigate whether one particular design resulted in improved preservation of BMD.

119 patients were randomized to receive either a proximally coated dual taper wedge stem, a proximally coated anatomic stem or a fully coated collarless triple tapered stem. Dual energy x-ray absorptiometry scans (Lunar iDXA, GE Healthcare, Madison, WI) assessed BMD across the seven Gruen zones pre-operatively, and post-operatively at 6-weeks, 1-year, and 2-years comparing the unoperated contralateral femur as a control.

BMD increased in zones one (2.5%), two (17.1%), three (13.0%), five (10%) and six (17.9%) for all stems. Greater preservation of BMD was measured on the lateral cortex (zone 2) for both the dual taper wedge and anatomic stems (p = 0.019). The dual taper wedge stem also demonstrated preservation of BMD in the medial calcar (zone 7) whilst the anatomic and triple taper stem declined in this region, however this was not statistically significant (p = 0.059). BMD decreased on average by 2.1% in the mid-diaphysis region, distal to the stem tip (zone 4) for all implants. All stems performed equivalently at final follow-up in all patient reported outcome measures.

Implant design was shown to impact BMD changes. All stems preserved bone at the metaphyseal level in early follow-up, which theoretically indicates favorable implant fixation. There was no significant stress shielding observed, however longer follow-up is required to elucidate the impact of this finding on implant survivorship.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 6 - 6
10 Feb 2023
Lawless A Ebert J Edwards P Aujla R Finsterwald M Dalgleish S Malik S Raymond R Giwnewer U Simpson A Grant M Leys T D'Alessandro P
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Hamstring grafts have been associated with reduced strength, donor site pain and muscle strains following Anterior Cruciate Ligament Reconstruction (ACLR). Traditional graft fixation methods required both semitendinosus and gracilis tendons to achieve a graft of sufficient length and diameter, but newer techniques allow for shorter, broad single tendon grafts.

This study seeks to compare the outcomes between Single Tendon (ST) and Dual Tendon (DT) ACLR, given there is no prospective randomised controlled trial (RCT) in the literature comparing outcomes between these options.

In this ongoing RCT: (ANZ Clinical Trials Registry ACTRN126200000927921) patients were recruited and randomised into either ST or DT groups. All anaesthetic and surgical techniques were uniform aside from graft technique and tibial fixation. 13 patients were excluded at surgery as their ST graft did not achieve a minimum 8mm diameter. 70 patients (34 ST, 36DT) have been assessed at 6 months, using PROMS including IKDC2000, Lysholm and Modified Cincinnati Knee, visual analog scale for pain frequency (VAS-F) and severity (VAS-S), dedicated donor site morbidity score, KT-1000 assessment, and isokinetic strength.

Graft diameters were significantly lesser in the ST group compared to the DT group (8.44mm/9.11mm mean difference [MD],-0.67mm; P<0.001). There was a significant and moderate effect in lower donor site morbidity in the ST group compared to the DT group (effect size [ES], 0.649; P = .01). No differences between groups were observed for knee laxity in the ACLR limb (P=0.362) or any of the patient-reported outcome measures (P>0.05). Between-group differences were observed for hamstrings strength LSI favouring the ST group, though these were small-to-moderate and non-significant (ES, 0.351; P = .147).

ST (versus DT) harvest results in significantly less donor site morbidity and this is the first prospective RCT to determine this. There were no differences between ST and DT hamstring ACLR were observed in PROMs, knee laxity and hamstring strength. Younger female patients tend to have inadequate single tendon size to produce a graft of sufficient diameter, and alternative techniques should be considered. Further endpoints include radiological analysis, longer term donor site morbidity, revision rates and return to sport and will continue to be presented in the future.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_3 | Pages 2 - 2
23 Jan 2024
Al-Jasim A Jarragh A Lari A Burhamah W Alherz M Nouri A Alshammari Y Alrefai S Alnusif N
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Background

Digital injuries are among the most common presentations to the emergency department. In order to sufficiently examine and manage these injuries, adequate, prompt, and predictable anaesthesia is essential. In this trial, we aim to primarily compare the degree of pain and anaesthesia onset time between the two-injection dorsal block technique (TD) and the single-injection volar subcutaneous block technique (SV). Further, we describe the temporal and anatomical effects of both techniques for an accurate delineation of the anesthetized regions.

Methods

A single-centre prospective randomized controlled trial involving patients presenting with isolated wounds to the fingers requiring primary repair under local anaesthesia. Patients were randomized to either the SV or TD blocks. The primary outcome was procedure-related pain (Numerical Rating Scale). Further, we assessed the extent of anaesthesia along with the anaesthesia onset time.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 25 - 25
23 Feb 2023
Marinova M Sundaram A Holtham K Ebert J Wysocki D Meyerkort D Radic R
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Cryocompression therapy is a non-invasive and non-pharmacological modality used in managing acute post-operative inflammation and pain. A prospective, randomised controlled trial (RCT) was undertaken to evaluate the effectiveness of a post-operative cryocompression protocol using the Game Ready™ (GR) device versus usual care on recovery following total knee arthroplasty (TKA).

A single centre RCT was conducted with 70 TKAs (68 patients) randomised to a 2-week intervention period consisting of treatment with GR cryocompression (n=33, 33.3% males) or a usual care protocol of ice with static compression using tubigrip (n=35, 54.3% males). Knee range of movement (ROM) (flexion and extension), a visual analogue pain score (VAS) and limb circumference were documented at day 1, 2 and 14, as well as 6 and 12 weeks post-surgery. ROM was also recorded at day 90, while medication use and length of hospital stay were documented. Patient reported outcome measures (PROMs) including the KOOS and patient satisfaction questionnaire were employed.

The GR group demonstrated 2.3° more (p=0.05) knee extension ROM overall, as well as 2. 8° more at day 1 (p=0.048), 3.8° at day 14 (p=0.007) and 5.4° at 3 months (p=0.017). There were no group differences (p>0.05) observed in pain (VAS), flexion ROM, limb circumference, opioid use or other PROMs. Across the full cohort, higher pain levels resulted in increased opioid intake (p=0.002), older patients used significantly less opioids (p<0.001) and males reported significantly less pain (VAS) than females (p=0.048).

Using GR following TKA is a safe, non-invasive tool that can be used to aid in the post-operative recovery period.

Patients using the GR cryocompression device gained significantly more extension ROM compared to the conventional ice with compression group, despite no other group differences.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 8 - 8
1 Mar 2021
Dimnjakovic D
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A tourniquet is usually used during ankle arthroscopy to allow for improved visibility and reduced operation time. However, clinical studies on knee arthroscopy have not demonstrated this to be true. In addition, Zengerink and van Dijk emphasized a limited tourniquet time in ankle arthroscopy as a possible factor to lower the complication rate even more. The purpose of this prospective randomized controlled trial was to examine the effect of tourniquet use on arthroscopic visualization, operative time, postoperative intra-articular bleeding, postoperative pain scores and outcome of anterior ankle arthroscopy.

A consecutive series of 50 patients who were scheduled for anterior ankle arthroscopy were randomized to have the surgery done either without the tourniquet inflated (25 patients) or with the tourniquet inflated (25 patients). The patients were evaluated by the course of the surgery, postoperative intra-articular bleeding, pain during the early postoperative period and by using the subjective and objective functional scores to evaluate the condition of the ankle before and 3 and 6 months after the surgery. The statistical analysis was performed with the normality of distribution tested by both Kolmogorov-Smirnov and Shapiro-Wilk tests. Appropriate parametric or non-parametric methods were then used to test statistical hypotheses, while the statistical significance (alpha, Type I error) was set at .05.

Fourty-nine patients were present at the final follow-up, 6 months after the surgery. The results between the groups were comparable regarding the duration of the operative procedure, consumption of sterile saline, visualisation and functional scores. Notable difference between the groups in favour of the non-tourniquet group was present regarding postoperative bleeding, but was not statistically significant. Statistically significant difference in favour of the non-tourniquet group was found regarding postoperative pain during several days in the early postoperative period.

Our study has shown that anterior ankle arthroscopy may be performed adequately without the use of a tourniquet and that it has the same operative course as in cases in which the tourniquet is used and functional outcomes which are not worse than in cases in which the tourniquet is used.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 72 - 72
1 Mar 2021
Gazendam A Bozzo A Schneider P Giglio V Wilson D Ghert M
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Given the low prevalence of sarcoma, international cooperation is necessary to recruit sufficient numbers of patients for surgical trials. The PARITY (Prophylactic Antibiotic Regimens in Tumour Surgery) trial is the first international multicentre trial in orthopedic oncology and successfully achieved target enrollment of 600 patients across 12 countries. It is important to reflect upon the challenges encountered and experiences gained to inform future trials. The objective of this study is to describe recruitment patterns and examine the differences in enrollment across different PARITY sites and identify variables associated with varying levels of recruitment.

Data from this study was obtained from the PARITY trial Methods Centre and correspondence data. We performed descriptive statistics to demonstrate the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, and sites that had dedicated research personnel. Two-tailed non-paired t-tests were performed to compare average monthly recruitment rates between groups with significance being set at alpha=0.05.

A total of 600 patients from 48 clinical sites and 12 countries were recruited from January 2013 through to October 2019. Average monthly enrollment increased every year of the study. There were 36 North American and 12 international sites. North American sites were able to set up significantly faster than international sites (19.3 vs. 28.3 months p=0.037). However, international sites had a significantly higher recruitment rate per month once active (0.2/month vs. 0.62/month, p=0.018). Of active sites, 40 (83%) had research support personnel and 8 (17%) sites did not. Sites with research personnel were able to reach ‘enrolment ready’ status significantly faster than sites without research support (19.6 vs. 30.7 months, p=0.032). However, there was no significant difference in recruitment rate per month once the sites began enrolling (0.28/month vs. 0.2/month, p=0.63). Trial sites that took longer than 1 year to recruit their first patient had 3x lower average recruitment rate compared to sites that were able to recruit their first patient within a year of being enrolment ready.

The PARITY trial is the first multicentre RCT in orthopaedic oncology. The PARITY investigators were able to increase the recruitment levels throughout the trial and generally avoid trial fatigue. This was a North American based trial which may explain the longer start up times internationally given the different regulatory bodies associated with drug-related trials. However, international sites should be considered critical as they were able to recruit significantly more patients per month once active. The absence of research support personnel should not preclude a site from inclusion. These sites took longer to setup but had no difference in monthly recruitment once active. This study will create a framework for identifying and targeting high yield sites for future randomized control trials within orthopaedic oncology to maximum recruitment and resource allocation. Data quality is another consideration that will be addressed in future analyses of the PARITY trial.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 22 - 22
1 Jul 2022
Butt U Khan Z Amin A Rehman G Afzal I Vuletic F Khan Z Shah I Shah J
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Abstract

Purpose

This study aims to compare the clinical and functional outcomes and donor site morbidity of anterior cruciate ligament reconstruction with hamstring tendon autograft and peroneus longus tendon autograft in patients with complete anterior cruciate ligament rupture.

Methods

Patients who underwent ACL reconstruction from February 2018 to July 2019 were randomly allocated into two groups (hamstring and peroneus longus). Functional scores (IKDC and Lysholm scores) and pain intensity by visual analogue score were recorded preoperatively, 3, 6months, 1, and 2 years postoperatively. Donor site morbidities were assessed with thigh circumference measurements in hamstring group and ankle scoring with the American foot and ankle score in peroneus longus group.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 11 - 11
17 Jun 2024
Lewis T Ferreira G Nunes G Ray R
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Background

Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma.

Methods

A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 17 - 17
7 Aug 2023
Arthur L Ghosh P Mohammad H Campi S Murray D Mellon S
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Abstract

Introduction

The Oxford Unicompartmental Knee Replacement's (OUKR's) fully-congruent design minimises polyethylene wear. Consequently, wear is a rare failure mechanism. Phase-3 OUKR linear wear at 5 years was higher than previous OUKR phases, but very low compared to fixed-bearing UKRs. This study aimed to measure OUKR bearing wear at 10 years and investigate factors that may affect wear.

Methodology

Bearing thickness for 39 OUKRs from a randomised study was calculated using radiostereometric analysis at regular intervals up to 10 years. Data for 39 and 29 OUKRs was available at 5 and 10 years, respectively. As creep occurs early, wear rate was calculated using linear regression between 6 months and 10 years. Relationships between wear and patient factors, fixation method, Oxford Knee Score (OKS), bearing position, and component position were analysed.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 1 - 1
7 Jun 2023
Gaston P Clement N Ohly N Macpherson G Hamilton D
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In this RCT the primary aim was to assess whether a short (125mm) Exeter V40 stem offered an equivalent hip specific function compared to the standard (150mm) stem when used for cemented total hip arthroplasty (THA). Secondary aims were to evaluate health-related quality of life (HRQoL), patient satisfaction, stem height and alignment, radiographic loosening, and complications between the two stems.

A prospective multicentre double-blind randomised control trial was conducted. During a 15-month period, 220 patients undergoing THA were randomised to either a standard (n=110) or short (n=110) stem Exeter. There were no significant (p≥0.065) differences in preoperative variables between the groups. Functional outcomes and radiographic assessment were undertaken at 1- and 2-years.

There were no differences (p=0.428) in hip specific function according to the Oxford hip score at 1-year (primary endpoint) or at 2-years (p=0.767) between the groups. The short stem group had greater varus angulation (0.9 degrees, p=0.003) when compared to the standard group and were more likely (odds ratio 2.42, p=0.002) to have varus stem alignment beyond one standard deviation from the mean. There were no significant (p≥0.083) differences in the Forgotten joint scores, EuroQol-5-Dimension, EuroQol-VAS, Short form 12, patient satisfaction, complications, stem height or radiolucent zones at 1 or 2-years between the groups.

The Exeter short stem offers equivalent hip specific function, HRQoL, patient satisfaction, and limb length when compared to the standard stem at 2-years post-operation. However, the short stem was associated with a greater rate of varus malalignment which may influence future implant survival.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 58 - 58
1 Aug 2020
Burgesson B Glazebrook M Daniels T Younger A
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Ankle arthrodesis and replacement are the widely accepted options in managing end-stage ankle arthritis. Ankle replacement as an alternate treatment option for ankle arthritis is relatively new and this is in large part to the successes observed with hip and knee arthroplasty for arthritis. Relative benefits of ankle replacement and arthrodesis remains a contentious topic. We conducted a multicenter pilot randomized controlled trial, first of its kind, comparing the clinical outcomes of ankle arthrodesis and ankle replacement in managing ankle arthritis. We hypothesized that clinical outcomes would be similar for both.

Patients recruited for this study were part of Canadian Orthopaedic Foot and Ankle Society (COFAS) Database. Canadian orthopaedic surgeons with fellowship training in foot and ankle surgery or extensive experience in the surgical treatment of end stage ankle arthritis determined whether the patient met the criteria for randomization, skeletal maturity, symptomatic ankle arthritis no longer amenable to non-operative management, and ability to give informed consent. Data was collected on patient demographics, follow-up time period, complication rates, and Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. Our analysis of clinical outcomes was divided into two parts: (1) comparison of pre and postoperative data for each cohort separately, and (2) comparison of outcome scores, and revision rates between both cohorts. We employed the Student's t-test and calculated effect sizes in assessing improvements in AOS and SF-36 scores from baseline to latest follow-up within and between the two groups. We also examined postoperative complication and reoperation rates in the study population using the standardized coding system for reoperations following ankle replacement and arthrodesis.

Thirty-nine ankles were enrolled in the study with a mean follow-up of 5.1 ± 2.8 years. Ankle osteoarthritis scale scores improved significantly from baseline and last follow-up in both groups. The average baseline AOS total score for ankle replacement improved from 59.4 ±15.9 to 38 ±20 at last follow-up (p-value 19.7 to 31.8 ±16.5 at last follow-up (p-value 25.4 compared to ankle replacement's 20.3 ±23. Two major complications (10.5%) were observed in the ankle replacement cohort while the ankle arthrodesis cohort saw four major complications (20%).

Clinical outcomes of ankle replacement and arthrodesis were comparable. The ankle arthrodesis cohort held a slight advantage over ankle replacement in improvement of AOS scores, though not statistically significant. Rates of major complications and reoperations were higher with ankle arthrodesis.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 46 - 46
1 Feb 2021
Zaid M Ward D Barry J
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Introduction

The efficacy of Virtual Reality (VR) as a teaching augment for arthroplasty has not been well examined for unfamiliar multistep procedures such as unicompartmental knee arthroplasty (UKA). This study sought to determine if VR improves surgical competence over traditional procedural preparation when performing a UKA.

Methods

22 Orthopaedic trainees were randomized to training sessions: 1) “VR group” with access to an immersive VR learning module that had been designed in conjunction with the manufacturer or 2) “Guide group” with access to manufacture's technique guide and surgical video. Both groups then performed a full UKA on SawBones models. Surgical competence was assessed via Objective Structures Assessment of Technical Skills (OSATS) validated rating system (max 25 points).


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 40 - 40
7 Jun 2023
Edwards T Soussi D Gupta S Khan S Patel A Patil A Badri D Liddle A Cobb J Logishetty K
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Superior teamwork in the operating theatre is associated with improved technical performance and clinical outcomes. Yet modern rota patterns, workforce shortages, and increasing complexity of surgery, means that there is less familiarity between staff and the required choreography. Immersive Virtual Reality (iVR) can successfully train surgical staff individually, however iVR team training has yet to be investigated. We aimed to design a multiplayer iVR platform for anterior approach total hip arthroplasty (AA-THA) and assess if multiplayer iVR training was superior to single player training for acquisition of both technical and non-technical skills.

An iVR platform with choreographed roles for the surgeon and scrub nurse was developed using Cognitive Task Analysis. Forty participants were randomised to individual or team iVR training. Individually- trained participants practiced alongside virtual avatar counterparts, whilst teams trained live in pairs. Both groups underwent five iVR training sessions over 6-weeks. Subsequently, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated theatre. Teams performed together and individually trained participants were randomly paired up. Videos were marked by two blinded assessors recording the NOTSS, NOTECHS II and SPLINTS scores - validated technical and non-technical scores assessing surgeon and scrub nurse skills. Secondary outcomes were procedure time and number of technical errors.

Teams outperformed individually trained participants for non-technical skills in the real-world assessment (NOTSS 13.1 ± 1.5 vs 10.6 ± 1.6, p =0.002, NOTECHS-II score 51.7 ± 5.5 vs 42.3 ± 5.6, p=0.001 and SPLINTS 10 ± 1.2 vs 7.9 ± 1.6, p = 0.004). They completed the assessment 28.1% faster (27.2 minutes ± 5.5 vs 41.8 ±8.9, p<0.001), and made fewer than half the number of technical errors (10.4 ± 6.1 vs 22.6 ± 5.4, p<0.001).

Multiplayer training leads to faster surgery with fewer technical errors and the development of superior non-technical skills for anterior approach total hip arthroplasty. The convention of surgeons and nurses training separately, but undertaking real complex surgery together, can be supplanted by team training, delivered through immersive virtual reality.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 11 - 11
7 Aug 2023
Khalid T Ben-Shlomo Y Bertram W Culliford L England C Henderson E Jameson C Jepson M Palmer S Whitehouse M Wylde V
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Abstract

Introduction

Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively via protein supplementation and exercise has the potential to improve outcomes after joint replacement. Before conducting a randomised controlled trial (RCT), a feasibility study is necessary to address key uncertainties and explore how to optimise trial design.

Methodology

Joint PREP is a feasibility study for a multicentre, two-arm, parallel group, pragmatic, RCT to evaluate the clinical and cost-effectiveness of prehabilitation for frail patients undergoing total hip or knee replacement. Sixty people who are ≥65 years of age, frail and scheduled to undergo total hip or knee replacement at 2–3 NHS hospitals will be recruited and randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group will be given a daily protein supplement and will be asked to follow a home-based, tailored daily exercise programme for 12 weeks before their operation, supported by fortnightly telephone calls from a physiotherapist. Embedded qualitative research with patients will explore their experiences of participating, reasons for non-participation and/or reasons for withdrawal or treatment discontinuation.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 82 - 82
23 Feb 2023
Rossignol SL Boekel P Rikard-Bell M Grant A Brandon B Doma K O'Callaghan W Wilkinson M Morse L
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Glenoid baseplate positioning for reverse total shoulder replacements (rTSR) is key for stability and longevity. 3D planning and image-derived instrumentation (IDI) are techniques for improving implant placement accuracy. This is a single-blinded randomised controlled trial comparing 3D planning with IDI jigs versus 3D planning with conventional instrumentation.

Eligible patients were enrolled and had 3D pre-operative planning. They were randomised to either IDI or conventional instrumentation; then underwent their rTSR. 6 weeks post operatively, a CT scan was performed and blinded assessors measured the accuracy of glenoid baseplate position relative to the pre-operative plan.

47 patients were included: 24 with IDI and 23 with conventional instrumentation. The IDI group were more likely to have a guidewire placement within 2mm of the preoperative plan in the superior/inferior plane when compared to the conventional group (p=0.01). The IDI group had a smaller degree of error when the native glenoid retroversion was >10° (p=0.047) when compared to the conventional group. All other parameters (inclination, anterior/posterior plane, glenoids with retroversion <10°) showed no significant difference between the two groups.

Both IDI and conventional methods for rTSA placement are very accurate. However, IDI is more accurate for complex glenoid morphology and placement in the superior-inferior plane. Clinically, these two parameters are important and may prevent long term complications of scapular notching or glenoid baseplate loosening.

Image-derived instrumentation (IDI) is significantly more accurate in glenoid component placement in the superior/inferior plane compared to conventional instrumentation when using 3D pre-operative planning. Additionally, in complex glenoid morphologies where the native retroversion is >10°, IDI has improved accuracy in glenoid placement compared to conventional instrumentation. IDI is an accurate method for glenoid guidewire and component placement in rTSA.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 73 - 73
1 Dec 2022
Woolfrey M Bolton C Woolfrey K Warchuk D
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Despite total knee arthroplasty demonstrating high levels of success, 20% of patients report dissatisfaction with their result.

Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, as according to the pattern theory of haptic perception, which stimulates improvements in pain and function.

Technologies that manipulate this sensory environment, such as textured insoles, have proven to be effective in improving gait patterns in patients with knee osteoarthritis. In regard to patients undergoing TKA using this new technology may prove beneficial as an adjunct to recovery as many patients suffer from further deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during procedure. We hypothesized that the Wellness Stasis Socks are a safe, cost-effective and easily scalable strategy to support TKA patients through their recovery.

Double-blinded, placebo-controlled randomized trial. Randomization using a computer-generated program . All study coordinators, healthcare personel and patients were blinded to patient groups. All surgical procedures were conducted by the same technique and orthopaedic surgeon. Intervention group: Wellness Stasis socks containing receptor point-activation technology. Control group: indentical appearing Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours . All additional post-operative protocols remained consistent between groups including same facility physiotherapy . Additional modalities (ice machines, soft-tissue massages, acupuncture) were prohibited. WOMAC questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness and physical function. G*Power software to determine minimum sample of 50 in each group. No patients were lost to follow up and all followed study protocol. Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA.

Cramer's V statistical analysis noted that other variables of Sex, BMI, ASA classification and Age were not statistically different between the control and intervention groups.

No statistical difference between groups in Preop Womac scores.

The data showed a consistent improvement in Womac scores for pain and stiffness at 2 weeks post op in the interventional group over the control group.

The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the intervention group compared to the control group.

There were no complications in either group associated the sock use.

The intervention proved to be a low cost and safe additional intervention post operatively from TKA to help patients improve with regard to pain, stiffness and physical function.

This study suggests this modality can be added to the list of other commonly used post op interventions such as cryocuffs, physiotherapy, and relaxation techniques as safe post op interventions to help patients improve post op TKA and can act as an adjunct in providing non narcotic pain control .


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 30 - 30
1 Oct 2020
Lombardi AV Duwelius PJ Morris MJ Hurst JM Berend KR Crawford DA
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Background

The purpose of this study is to evaluate the early perioperative outcomes after primary knee arthroplasty with the use of a smartphone-based exercise and educational platform compared to a standard of care control group.

Methods

A multicenter prospective randomized control trial was conducted evaluating the use of the mymobility smartphone-based care platform for primary total knee arthroplasty (TKA) and unicondylar knee arthroplasty (UKA). Patients in the control group (224 patients) received the respective institution's standard of care typically with formal physical therapy. Those randomized to mymobility treatment group (192 patients) were provided an Apple Watch and mymobility smartphone application. The treatment group was not initially prescribed physical therapy, but could if their surgeon determined it necessary. Early outcomes assessed included 90-day knee range of motion, KOOS Jr scores, 30-day single leg stance (SLS) time, Time up and Go (TUG) time and need for manipulation under anesthesia (MUA). There was no significant difference in age, BMI or gender between groups.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 21 - 21
1 Nov 2021
DeBenedetti A Della Valle CJ Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal ion levels in patients undergoing THA with either a standard or modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or a standard polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Only patients without a prior history of metal implants in their body were eligible for inclusion, thus isolating serum metal ions to the prosthesis itself. Serum metal ion levels were drawn pre-operatively and at 1 year postoperatively. Power analysis determined that 40 patients (20 in each group) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power assuming a pooled standard deviation of 0.31 ppb and alpha=0.05; an additional 30% were enrolled to account for potential dropouts.

53 patients were enrolled, with 22 patients in the modular dual-mobility group and 20 in the standard cohort with data available at one-year. No differences in the serum cobalt (0.17 ppb [range 0.07 to 0.50] vs. 0.19 ppb [range 0.07 to 0.62], p = 0.51) or chromium levels (0.19 ppb [range 0.05 to 0.56] vs. 0.16 ppb [range 0.05 to 0.61], p = 0.23) were identified.

At 1 year postoperatively, no differences in serum cobalt or chromium levels were identified with this design of a modular dual mobility bearing when compared to a standard polyethylene bearing.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 24 - 24
1 Aug 2020
Salimian A Slullitel P Grammatopoulos G Kreviazuk C Beaulé P Wilkinson JM
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The use of cementless acetabular components is currently the gold standard for treatment in total hip arthroplasty (THA). Porous coated cups have a low modulus of elasticity that enhances press-fit and a surface that promotes osseointegration. Monoblock acetabular cups represent a subtype of uncemented cup with the liner moulded into the metal shell, minimizing potential backside wear and eliminating the chance of mal-seating. The aim of this study was to compare the short-term clinical and radiographic performances of a modular cup with that of a monoblock cup, with particular interest in the advent of lucent lines and their correlation with clinical outcomes.

In this multi-surgeon, prospective, randomized, controlled trial, 86 patients undergoing unilateral THA were recruited. Participants were randomized to either a porous-coated, modular metal-on-polyethylene (MoP) acetabular component (n=46) or a hydroxyapatite (HA)- and titanium-coated monoblock shell with ceramic-on-ceramic (CoC) bearing (n=42). The porous-coated cup had an average pore size of 250 microns with an average volume porosity of 45%, whereas the monoblock shell had an average pore size of 300 microns with an average volume porosity of 48% and a HA coating thickness of 80 nm. There were no baseline demographic differences between both groups regarding sex, age, body mass index (BMI), or American Society of Anaesthesia (ASA) class (p>0.05). All of the sockets were under-reamed by 1 mm. Radiographs and patient-reported outcome measures (PROMs), including modified Harris Hip Score (mHHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and University of California at Los Angeles (UCLA) Hip Score, were available for evaluation at a minimum of 2 years of follow-up. A radiolucent distance between the cup and acetabulum of ≥0.5 mm was defined as gap if it was diagnosed from outset or as radiolucency if it had sclerotic edges and was found on progressive x-ray analyses.

Thirty-two gaps (69%) were found in the modular cup group and 28 (6%) in the monoblock one (p=0.001). Of the former, 17 filled the gaps whereas 15 turned into a radiolucency at final assessment. Of the latter, only 1 of the gaps turned into a radiolucency at final follow-up (p 0.05) in both groups. Only the porous-coated cup was an independent predictor of lucent lines (OR:0.052, p=0.007). No case underwent revision surgery due to acetabular loosening during the study period. Only 2 cases of squeaking were reported in the CoC monoblock shell.

Both porous-coated modular and hydroxyapatite-coated monoblock cups showed successful clinical results at short-term follow-up, however, the former evidenced a significantly higher rate of radiolucent line occurrence, without any association with PROMs. Since these lines indicate the possibility of future cup loosening, longer follow-up and assessment are necessary.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_10 | Pages 16 - 16
1 Aug 2021
Gupta V Thomas C Parsons H Metcalfe A Foguet P King R
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Total hip arthroplasty (THA) is one of the most successful surgical procedures of modern times, however debate continues as to the optimal orientation of the acetabular component and how to reliably achieve this. We hypothesised that functional CT-based planning with patient specific instruments using the Corin Optimised Positioning System (OPS) would provide more accurate component alignment than the conventional freehand technique using 2D templating.

A pragmatic single-centre, patient-assessor blinded, randomised control trial of patients undergoing THA was performed. 54 patients (age 18–70) were recruited to either OPS THA or conventional THA. All patients received a cementless acetabular component. Patients in both arms underwent pre- and post-operative CT scans, and four functional x-rays (standing and seated). Patients in the OPS group had a 3D surgical plan and bespoke guides made. Patients in the conventional group had a surgical plan based on 2D templating x-rays, and the pre-operative target acetabular orientation was recorded by the surgeon. The primary outcome measure was the difference between planned and achieved acetabular anteversion and was determined by post-operative CT scan performed at 6 weeks. Secondary outcome measures included Hip disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), EQ-5D and adverse events.

In the OPS group, the achieved acetabular anteversion was within 10° of the plan in 96% of cases, compared with only 76% of cases in the conventional group. For acetabular inclination, the achieved position in the OPS group was within 10° of the plan in 96% of cases, compared with in only 84% of cases in the conventional group. These differences were not statistically significant. The clinical outcomes were comparable between the two groups.

Large errors in acetabular orientation appear to be reduced when functional CT-based planning and patient-specific instruments are used compared to the freehand technique, but no statistically significant differences were seen in the difference between planned and achieved angles. Larger studies are needed to analyse this in more detail and to determine whether the reduced numbers of outliers lead to improved clinical outcomes.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 9 - 9
1 Dec 2021
Edwards T Soussi D Gupta S Patel A Liddle A Khan S Cobb J Logishetty K
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Abstract

Objectives

Non-technical skills including teamwork play a pivotal role in surgical outcomes. Virtual reality is effective at improving technical skills, however there is a paucity of evidence on team-based virtual reality (VR) training. This study aimed to assess if multiplayer virtual reality training was superior to solo training for acquisition of both technical and non-technical skills in learning the complex anterior approach total hip arthroplasty operation.

Methods

10 novice surgeons and 10 novice scrub nurses, were randomised to solo or team virtual reality training to perform anterior approach total hip arthroplasty. Solo participants trained with virtual avatar counterparts, whilst teams trained in pairs (surgeon and scrub nurse). Both groups underwent 5 VR training sessions over 6 weeks. Then, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated operating theatre. Teams performed together and solo participants were randomly paired up with a solo player of the opposite role. Videos of the assessment were marked by two blinded expert assessors. Outcomes were procedure time, procedural errors from an expert pre-defined protocol and acetabular component positioning. Non-technical skills were assessed using the NOTECHs II and NOTSS scores.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 32 - 32
1 Dec 2021
Edwards T Khan S Patel A Gupta S Soussi D Liddle A Cobb J Logishetty K
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Abstract

Objectives

Evidence supporting the use of immersive virtual reality (iVR) training in orthopaedic procedures is rapidly growing. However, the impact of the timing of delivery of this training is yet to be tested. This study investigated whether spaced iVR training is more effective than massed iVR training for novices learning hip arthroplasty.

Methods

24 medical students with no hip arthroplasty experience were randomised to learning total hip arthroplasty using the same iVR simulation training either once-weekly or once-daily for four sessions. Participants underwent a baseline physical world assessment to orientate an acetabular component on a saw bone pelvis, and a baseline knowledge test. In iVR, we recorded procedural errors, time, numbers of prompts required and path lengths of the hands and head across 4 sessions. To assess skill retention, the iVR and baseline physical world assessments were repeated at one-week and one-month.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 37 - 37
7 Jun 2023
Edwards T Kablean-Howard F Poole I Edwards J Karia M Liddle A Cobb J Logishetty K
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Superior team performance in surgery leads to fewer technical errors, reduced mortality, and improved patient outcomes. Scrub nurses are a pivotal part of this team, however they have very little structured training, leading to high levels of stress, low confidence, inefficiency, and potential for harm. Immersive virtual reality (iVR) simulation has demonstrated excellent efficacy in training surgeons. We tested the efficacy of an iVR curriculum for training scrub nurses in performing their role in an anterior approach total hip arthroplasty (AA-THA).

Sixty nursing students were included in this study and randomised in a 1:1 ratio to learning the scrub nurse role for an AA-THA using either conventional training or iVR. The training was derived through expert consensus with senior surgeons, scrub nurses and industry reps. Conventional training consisted of a 1-hour seminar and 2 hours of e-learning where participants were taught the equipment and sequence of steps. The iVR training involved 3 separate hour-long sessions where participants performed the scrub nurse role with an avatar surgeon in a virtual operation. The primary outcome was their performance in a physical world practical objective assessment with real equipment. Data were confirmed parametric using the Shapiro-Wilk test and means compared using the independent samples student's t-test.

53 participants successfully completed the study (26 iVR, 27 conventional) with a mean age of 31±9 years. There were no significant differences in baseline characteristics or baseline knowledge test scores between the two groups (p>0.05). The iVR group significantly outperformed the conventionally trained group in the real-world assessment, scoring 66.9±17.9% vs 41.3±16.7%, p<0.0001.

iVR is an easily accessible, low cost training modality which could be integrated into scrub nursing curricula to address the current shortfall in training. Prolonged operating times are strongly associated with an increased risk of developing serious complications. By upskilling scrub nurses, operations may proceed more efficiently which in turn may improve patient safety.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 29 - 29
1 Dec 2022
Alolabi B Shanthanna H Czuczman M Moisiuk P O'Hare T Khan M Forero M Davis K Moro JK Foster G Thabane L
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Interscalene brachial plexus block is the standard regional analgesic technique for shoulder surgery. Given its adverse effects, alternative techniques have been explored. Reports suggest that the erector spinae plane block may potentially provide effective analgesia following shoulder surgery. However, its analgesic efficacy for shoulder surgery compared with placebo or local anaesthetic infiltration has never been established.

We conducted a randomised controlled trial to compare the analgesic efficacy of pre-operative T2 erector spinae plane block with peri-articular infiltration at the end of surgery. Sixty-two patients undergoing arthroscopic shoulder repair were randomly assigned to receive active erector spinae plane block with saline peri-articular injection (n = 31) or active peri-articular injection with saline erector spinae plane block (n = 31) in a blinded double-dummy design. Primary outcome was resting pain score in recovery. Secondary outcomes included pain scores with movement; opioid use; patient satisfaction; adverse effects in hospital; and outcomes at 24 h and 1 month.

There was no difference in pain scores in recovery, with a median difference (95%CI) of 0.6 (-1.9-3.1), p = 0.65. Median postoperative oral morphine equivalent utilisation was significantly higher in the erector spinae plane group (21 mg vs. 12 mg; p = 0.028). Itching was observed in 10% of patients who received erector spinae plane block and there was no difference in the incidence of significant nausea and vomiting. Patient satisfaction scores, and pain scores and opioid use at 24 h were similar. At 1 month, six (peri-articular injection) and eight (erector spinae plane block) patients reported persistent pain.

Erector spinae plane block was not superior to peri-articular injection for arthroscopic shoulder surgery.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 14 - 14
1 Oct 2022
Williamson E Boniface G Marian I Dutton S Maredza M Petrou S Garrett A Morris A Hansen Z Ward L Nicolson P Barker K Fairbank J Fitch J Rogers D Comer C French D Mallen C Lamb S
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Purpose and background

To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition.

Methods and results

A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness.

Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 7 - 7
17 Jun 2024
Heinz N Bugler K Clement N Low X Duckworth A White T
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Background

Studies have compared open reduction internal fixation (ORIF) with fibular nail fixation (FNF) and shown reduced wound complications with minimal difference to PROMS in the short term. Our aim is to compare long-term outcomes for unstable ankle fractures at 10 year follow up.

Methods

Patients from a previously conducted RCT were contacted at a minimum of 10 years post intervention at a single study centre. Case notes were reviewed, and patient reported outcome measures acquired at 10 years.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 127 - 127
1 Nov 2021
Batailler C Lording T Naaim A Servien E Cheze L Lustig S
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Introduction and Objective

In recent studies, robotic-assisted surgical techniques for unicompartmental knee arthroplasty (UKA) have demonstrated superior implant positioning and limb alignment compared to a conventional technique. However, the impact of the robotic-assisted technique on clinical and functional outcomes is less clear. The aim of this study was to compare the gait parameters of UKA performed with conventional and image-free robotic-assisted techniques.

Materials and Methods

This prospective, single center study included 66 medial UKA, randomized to a robotic-assisted (n=33) or conventional technique (n=33). Gait analysis was performed on a treadmill at 6 months to identify changes in gait characteristics (walking speed, each degree-of-freedom: flexion–extension, abduction–adduction, internal-external rotation and anterior-posterior displacement). Clinical results were assessed at 6 months using the IKS score and the Forgotten Joint Score. Implants position was assessed on post-operative radiographs.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 58 - 58
1 Mar 2021
Dehghan N Nauth A Schemitsch E Vicente M Jenkinson R Kreder H McKee M
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Unstable chest wall injuries have high rates of mortality and morbidity. These injuries can lead to respiratory dysfunction, and are associated with high rates of pneumonia, sepsis, prolonged ICU stays, and increased health care costs. Numerous studies have demonstrated improved outcomes with surgical fixation compared to non-operative treatment. However, an adequately powered multi-centre randomized controlled study using modern fixation techniques has been lacking.

We present a multi-centred, prospective, randomized controlled trial comparing surgical fixation of acute, unstable chest wall injuries with the current standard of non-operative management. Patients aged 16–85 with a flail chest (3 or more consecutive, segmental, displaced rib fractures), or severe deformity of the chest wall, were recruited from multiple trauma centers across North America. Exclusion criteria included: severe pulmonary contusion, severe head trauma, randomization>72 hours from injury, inability to perform surgical fixation within 96 hours from injury (in those randomized to surgery), fractures of the floating ribs, or fractures adjacent to the spine not amendable to surgical fixation. Patients were seen in follow-up for one year. The primary outcome was days free from mechanical ventilation in the first 28 days following injury. Secondary outcomes were days in ICU, rates of pneumonia, sepsis, need for tracheostomy, mortality, general health outcomes, pulmonary function testing, and other complications of treatment. A sample size of 206 was required to detect a difference of 2 ventilator-free days between the two groups, using a 2-tailed alpha error of 0.05 and a power of 0.80.

A total of 207 patients were recruited from 15 sites across Canada and USA, from 2011–2018. Ninety-nine patients were randomized to non-operative treatment, and 108 were randomized to surgical fixation. Overall, the mean age was 53 years, and 75% of patients were male, with 25% females. The commonest mechanisms of injury were: motor vehicle collisions (34%), falls (20%), motorcycle collisions (14%), and pedestrian injuries (11%). The mean injury severity score (ISS) at admission was 26, and patients had a mean of 10 rib fractures. Eighty-nine percent of patients had pneumothorax, 76% had haemothorax, and 54% had pulmonary contusion. There were no differences between the two groups in terms of demographics. The final results will be available and presented at the COA meeting in Halifax.

This is the largest randomized controlled trial to date, comparing surgical fixation to non-operative treatment of unstable chest wall and flail chest injuries. The results of this study will shed light on the best treatment options for patients with such injuries, help understand outcomes, and guide treatment. The final results will be available and presented at the COA meeting in Halifax.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 65 - 65
1 Oct 2019
Beaulé PE Slullitel PA Dobransky J Kreviazuk C Kim JK Grammatopoulos G
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Introduction

Porous coated cups have a low modulus of elasticity that enhances press-fit and a surface that promotes osseointegration as well as permitting modularity. Monoblock ceramic acetabular cups represent a subtype of uncemented cup permitting the use of large femoral heads. The aim of this study was to compare the short-term clinical and radiographic performances of both cups.

Methods

This was a prospective RCT of 86 unilateral THA patients (M: 40, F: 48; mean age: 59.5 ± 10.6) randomized to either a porous-coated, modular metal-on-polyethylene (MoP) acetabular component (pore size 250µm, 45% mean volume porosity)(n=46) or a hydroxyapatite (HA) and titanium-coated monoblock shell with ceramic-on-ceramic(CoC) bearing (pore size 300µm, 48% mean volume porosity & 80nm HA coating thickness)(n=42). All sockets were under-reamed by 1 mm. Two-year radiographs and patient-reported outcomes (PROMs) were available.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 49 - 49
1 Jul 2020
Lapner P Laneuville O Uhthoff HK Zhang T Howard L Pollock J Ruggiero S Trudel G
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Tears of the rotator cuff tendons are a very common entity. Despite recent advances in arthroscopic rotator cuff repair, the re-tear rate remains high. Thus, new methods to improve healing rates following rotator cuff repair must be sought. The purpose of this prospective randomized double-blind controlled study is to compare the functional outcomes and healing rates of an adjuvant pre-operative bone microfracture technique prior to arthroscopic cuff repair.

Patients undergoing arthroscopic rotator cuff repair were randomized to receive either a percutaneous bone microfracture of the supraspinatus footprint or a “soft tissue needling” technique, in which the pin was passed through the peripheral edges of the rotator cuff, five-seven days prior to index surgery, under ultrasound guidance. Follow-ups were completed at 3, 6, 12 and 24 months post-operatively. Healing status was determined by ultrasound at 6 and 24 months. The primary objective was to compare the WORC score at 24 months. Secondary objectives included the healing status via ultrasound, the Constant, and the ASES scores. A sample size calculation determined that 90 patients provided 80% power to detect a statistical difference between groups.

Baseline demographic data did not differ between groups. No statistical differences were detected in the WORC outcome at any time points (p=0.47, baseline, p=0.60, 3 months, p=0.79, 6 months, p=0.50, 12 months, p=0.54, 24 months). Healing rates did not differ between groups (P=0.34) and no differences were observed in the ASES or Constant Scores at all time-points. Statistically significant improvements occurred in both groups from baseline to all time points in all clinical outcome scores (p < 0 .0001).

No statistically significant differences in primary or secondary outcomes were identified between pre-operative bone microfracture and soft tissue needling techniques prior to arthroscopic rotator cuff repair. This study does not support pre-operative microfracture as a adjuvant technique prior to arthroscopic cuff repair.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 31 - 31
1 Jul 2020
Lo IKY Bois A LeBlanc J Woodmass J Kwong C Gusnowski E Lo A
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Rotator cuff disease encompasses a spectrum from partial to full thickness tears. Despite being 2–3 times more common than full–thickness tears, effective non-operative treatment for partial thickness tears has remained elusive. Platelet enriched plasma (PRP) has been proposed to enhance rotator cuff healing by enhancing the natural healing cascade. However, its utility in rotator cuff disease remains controversial. The purpose of this study was to compare the patient reported outcomes between PRP and corticosteroid injection in patients with symptomatic partial thickness tears.

This double blind randomized controlled trial enrolled patients with symptomatic, partial thickness rotator cuff tears or rotator cuff tendinopathy proven on ultrasound or MRI. Patients were randomized to either corticosteroid or PRP ultrasound-guided injection of the affected shoulder. Patients completed patient reported outcomes at 6 weeks and 12 weeks. The primary outcome was Visual Analog Scale (VAS) pain scores. Secondary outcomes included the Western Ontario Rotator Cuff (WORC) index, American Shoulder and Elbow Surgeons (ASES) score, and failure of non-operative management as determined by consent for surgery or progression to operative intervention.

Ninety-nine patients were enrolled in the study with equal demographics between the two groups. Taking into account pre-injection scores, patients with PRP injections demonstrated a statistically significant improvement in VAS scores compared to patients receiving corticosteroid injections at 12 weeks (p=0.045) but not at 6 weeks (p=0.704). There was no difference in other outcome measures or progression of the two groups to surgical intervention.

The use of PRP in the management of partial thickness rotator cuff tears demonstrates significant improvement of pain scores at 12 week follow up compared to corticosteroid injections. However, this did not affect the rate of progression to surgical intervention. Continued study is required to determine the utility of PRP in this patient population.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 61 - 61
1 Oct 2018
Hannon CP Calkins TE Li J Culvern C Darrith B Nam D Gerlinger TL Della Valle CJ
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Introduction

Opioids are an important component of multimodal analgesia, but improper utilization places patients at risk for overdose and addiction. The purpose of this randomized controlled trial is to determine whether the quantity of opioid pills prescribed at discharge is associated with the total amount of opioids consumed or unused by patients after total hip (THA) and knee (TKA) arthroplasty.

Methods

304 Opioid naïve patients undergoing THA or TKA were randomized to receive a prescription for either 30 or 90 5mg oxycodone immediate release (OxyIR) tablets at discharge. All patients received acetaminophen, meloxicam, tramadol and gabapentin perioperatively. Daily opioid consumption, reported in morphine equivalent dose (MED), number of unused OxyIR, and pain scores were calculated for 30 days postoperatively with a patient-completed medication diary. The number of OxyIR refills and total MED received were recorded for 90 days postoperatively. Power analysis determined that 141 patients per group were necessary to detect a 25% reduction in means in opiate consumption between groups. Statistical analysis involved t-test, rank sum, and chi-squared tests with alpha=0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 64 - 64
1 Oct 2018
MacDonald SJ Culliton SE Bryant D Hibbert K Chesworth BM
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Purpose

Patient expectations of total knee arthroplasty (TKA) can be managed through education. E-learning is the application of information technology to education. Providing information to patients at the place and time of their choosing, e-learning has the potential to broaden the reach of existing services for patients. This study evaluated whether an e-learning tool could affect whether patients felt their expectations were met and whether they were satisfied with surgery one year following primary TKA.

Method

We recruited consecutive patients with osteoarthritis and randomized them to either standard patient education (n=207), or to our standard patient education plus a new e-learning tool (n=209). Preoperative measures were completed following the patients’ Pre-Admission clinic (PAC) visit and prior to accessing the e-learning tool. Postoperative patient reported outcome measures (PROMs) were completed at six weeks, three months and one year after TKA.

We used the Postoperative Expectation Questionnaire to measure the degree to which patient expectations had been met and the Patient Acceptable Symptom State (PASS) question to measure patient satisfaction at one year postoperative. We collected several PROMs for descriptive purposes including: new Knee Society Knee Scoring System (KSS); (Pre-Op and Post-Op versions), Knee injury and Osteoarthritis Outcome Score (KOOS), the Medical Outcomes Study 12-Item Short Form Health Survey, version 2 (SF-12), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), University of California at Los Angeles (UCLA) Activity Score, and the Social Role Participation Questionnaire (SRPQ).


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 34 - 34
23 Jun 2023
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A
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In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA.

96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups.

Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups (p=0.825, p=1.000, p=0.558). At 2 years, 7 (32-mm) versus 4 (36–44-mm) patients had elevated ions. At 5 years, 6 (32-mm) versus 7 (36–44-mm) patients had elevated ions. There was no difference in either OHS (p=0.665) or UCLA (p=0.831) between patients with or without elevated blood metal ions.

5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 91 - 91
23 Feb 2023
Cecchi S Aujla R Edwards P Ebert J Annear P Ricciardo B D'Alessandro P
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Avulsion of the proximal hamstring tendon from the ischial tuberosity is an uncommon but significant injury. Recent literature has highlighted that functional results are superior with surgical repair over non-surgical treatment. Limited data exists regarding the optimal rehabilitation regime in post-operative patients. The aim of this study was to investigate the early interim patient outcomes following repair of proximal hamstring tendon avulsions between a traditionally conservative versus an accelerated rehabilitation regimen.

In this prospective randomised controlled trial (RCT) 50 patients underwent proximal hamstring tendon avulsion repair, and were randomised to either a braced, partial weight-bearing (PWB) rehabilitation regime (CR = 25) or an accelerated, unbraced, immediate full weight-bearing (FWB) regime (AR group; n = 25). Patients were evaluated preoperatively and at 3 months after surgery, using the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT), visual analog pain scale (VASP), Tegner score, and 12-item Short Survey Form (SF-12). Patients also filled in a diary questioning postoperative pain at rest from Day 2, until week 6 after surgery. Primary analysis was by per protocol and based on linear mixed models.

Both groups, with respect to patient and characteristics were matched at baseline. Over three months, five complications were reported (AR = 3, CR = 2). At 3 months post-surgery, significant improvements (p<0.001) were observed in both groups for all outcomes except the SF-12 MCS (P = 0.623) and the Tegner (P = 0.119). There were no significant between-group differences from baseline to 3 months for any outcomes, except for the SF-12 PCS, which showed significant effects favouring the AR regime (effect size [ES], 0.76; 95% CI, 1.2-13.2; P = .02).

Early outcomes in an accelerated rehabilitation regimen following surgical repair of proximal hamstring tendon avulsions, was comparable to a traditionally conservative rehabilitation pathway, and resulted in better physical health-related quality of life scores at 3 months post-surgery. Further long term follow up and functional assessment planned as part of this study.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_14 | Pages 2 - 2
10 Oct 2023
Heinz N Bugler K Clement N Low X Duckworth A White T
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To compare the long-term outcomes of fibular nailing and plate fixation for unstable ankle fractures in a cohort of patients under the age of 65 years.

Patients from a previously conducted randomized control trial comparing fibular nailing and plate fixation were contacted at a minimum of 10 years post intervention at a single study centre. Short term data were collected prospectively and long-term data were collected retrospectively using an electronic patient record software.

Ninety-nine patients from one trauma centre were included (48 fibular nails and 51 plate fixations). Groups were matched for gender (p = 0.579), age (p = 0.811), body mass index (BMI)(p = 0.925), smoking status (p = 0.209), alcohol status (p = 0.679) and injury type (p = 0.674). Radiographically at an average of 2 years post-injury, there was no statistically significant difference between groups for development of osteoarthritis (p = 0.851). Both groups had 1 tibio-talar fusion (2% of both groups) secondary to osteoarthritis with no statistically significant difference in overall re-operation rate between groups identified (p = 0.518,). Forty-five percent (n=42) of patients had so far returned patient reported outcome measures at a minimum of 10 years (Fibular nail n=19, plate fixation n=23). No significant difference was found between groups at 10 years for the Olerud and Molander Ankle Score (p = 0.990), the Manchester-Oxford Foot Questionnaire (p = 0.288), Euroqol-5D Index (p = 0.828) and Euroqol-5D Visual Analogue Score (p = 0.769).

The current study illustrates no difference between fibular nail fixation and plate fixation at a long-term follow up of 10 years in patients under 65 years old, although the study is currently under powered.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 71 - 71
1 Dec 2022
Gazendam A Ekhtiari S Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery.

The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups.

As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X).

The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 25 - 25
2 May 2024
Ajula R Mayne A Cecchi S Ebert J Edwards P Davies P Ricciardo B Annear P D'Alessandro P
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Proximal hamstring tendon avulsion from the ischial tuberosity is a significant injury, with surgical repair shown to have superior functional outcomes compared to non-surgical treatment. However, limited data exists regarding the optimal rehabilitation regime following surgical repair. The aim of this study was to investigate patient outcomes following repair of proximal hamstring tendon avulsions between a conservative (CR) versus an accelerated rehabilitation (AR) regimen.

This prospective randomized controlled trial (RCT) randomised 50 patients undergoing proximal hamstring tendon repair to either a braced, partial weight-bearing rehabilitation regime (CR=25) or an accelerated, unbraced regime, that permitted full weight-bearing as tolerated (AR=25).

Patients were evaluated pre-operatively and at 3 and 6 months post-surgery, via patient-reported outcome measures (PROMs) including the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT) and 12-item Short Form Health Survey (SF-12). Primary analysis was per protocol and based on linear mixed models.

Both groups were matched at baseline with respect to patient characteristics. All PROMs improved (p>0.05) and, while the AR group reported a significantly better Physical Component Score for the SF-12 at 3 months (p=0.022), there were no other group differences. Peak isometric hamstrings strength and peak isokinetic quadriceps and hamstrings torque symmetry were all comparable between groups (p>0.05). Three re-injuries have been observed (CR=2, AR=1).

After proximal hamstring repair surgery, post-operative outcomes following an accelerated rehabilitation regimen demonstrate comparable outcomes to a traditionally conservative rehabilitation pathway, albeit demonstrating better early physical health-related quality of life scores, without an increased incidence of early re-injury.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 18 - 18
1 Apr 2022
Kayani B Baawa J Fontalis A Tahmassebi J Wardle N Middleton R Hutchinson J Haddad FS
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This study reports the ten-year polyethylene liner wear rates, incidence of osteolysis, clinical outcomes and complications of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA).

Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. Blinded observers recorded predefined outcomes in 262 study patients at regular intervals for ten years following THA.

At ten years follow-up, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C were associated with increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non-significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up when measuring normalised Western Ontario and McMaster Universities Osteoarthritis Index(p=0.410), short-form-36 (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p=0.451).

The use of UHMWPE was associated with progressively increased annual liner wear rates after THA. At ten years follow-up, this translated to UHMWPE leading to an increased incidence of osteolysis and aseptic loosening requiring revision THA, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_1 | Pages 9 - 9
1 Jan 2019
Wickramasinghe N Maempel J Clement N Duckworth A Keating J
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Limited long term data exists comparing operatively and non-operatively treated Achilles tendon ruptures. A previous randomised controlled trial comparing early outcomes showed a short term advantage for surgery, but there are no long term prospective randomised comparisons. Our aim was to determine whether surgery conferred long term benefits in terms of patient reported outcomes or re-rupture.

64 patients (80%) were followed up with postal questionnaires. Patients were asked to complete the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS) and EQ-5D questionnaires, and to report re-ruptures.

32 patients were treated non-operatively and 32 operatively; 59 completed the SMFA and 64 the ATRS and EQ-5D assessments. There was no significant difference in SMFA score (median 1.09, IQR 4.89 in the cast group versus 2.17 and 7.07 in the operative group; p=0.347), ATRS (median 96, IQR 18 versus 93 and 15; p=0.509), EQ-5D Index (median 1.0, IQR 0.163 versus 1.0 and 0.257; p=0.327) and EQ-5D Visual Analogue Score (median score 85, IQR 15 versus 85 and 24; p=0.650). There were 2 re-ruptures in the operative group and 4 in the non-operative group (p=0.067).

This is the first prospective, randomised, long term report comparing operative and non-operative management. At follow up between 13–17 years after injury, patients reported good function and health related quality of life. There was no significant difference in re-rupture rate between the treatment groups.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 32 - 32
1 Mar 2021
Lapner P McRae S Leiter J McIlquham K MacDonald P
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Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. No previous comparative trials have reported on the long-term follow-up of single and double row fixation in arthroscopic cuff repair. The purpose of this study was to compare the long-term functional outcomes of single-row and double-row suture techniques for repair of the rotator cuff 10-years post-operatively.

Ninety patients undergoing arthroscopic rotator cuff repair were randomized to receive either single-row or double-row repair. The primary objective was to compare the Western Ontario Rotator Cuff Index (WORC) score 10-years post-operatively. Secondary objectives included comparison of the Constant, and American Shoulder and Elbow Surgeons (ASES) scores and supraspinatus strength between groups. Out of 90 patients originally randomized, 57 returned for the long-term 10-year follow-up.

Baseline demographic data did not differ between groups. The WORC score was not significantly different between groups at long-term follow-up (p=0.13). No statistical differences were observed between groups for the Constant (p=0.51), ASES (p=0.48) scores, or strength scores (p=0.93). A significant improvement was observed between pre-operative and the final 10-year follow-up. There were no differences observed in all outcomes between two and 10-years post-operatively.

No statistically significant differences in functional or quality of life outcomes were identified between single-row and double-row fixation techniques at long-term follow-up.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 58 - 58
1 Jul 2020
Hamilton D Simpson H Beard D Barker K MacFarlane G Stoddart A Murray G
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There is a lack of evidence as to the best way to deliver rehabilitation following TKA. Previous work has suggested that postoperative physiotherapy applied to all patients is not effective at improving one-year post-surgical outcomes. The aim of this study was to target physiotherapy to those at risk of poor outcome following TKA, and to determine if a therapist-led intervention offered superior results compared to a home-exercise based protocol in this ‘at risk’ group.

The Targeted Rehabilitation to Improve Outcomes (TRIO) study was a prospective randomised controlled trial run at 15-centres in the UK. Patients were identified as ‘potential poor outcome’ based on an Oxford Knee Score (OKS) classification at 6-weeks post-surgery and randomised to either therapist-led or home-exercise based protocols. Patients were reviewed by a physiotherapist and commenced 18-exercise sessions over 6-weeks. The therapist-led group undertook a progressive functional protocol (modified weekly in 1-1 contact sessions) in contrast to the static home-exercise based regime. Evaluation took place following rehabilitation intervention, then at 6-months and 1-year post-surgery. Primary outcome was comparative group OKS at 1-year. Secondary outcomes included, ‘worst’ and ‘average’ pain scores, OXS and EQ-5D, and satisfaction questionnaire. Health economic (cost-utility) analysis was undertaken from NHS perspective up to 1-year post-surgery. Incremental cost per Quality Adjusted Life Years (QALYs) were calculated from intervention costs, patient reported primary and secondary care usage, and EQ-5D data.

4264 patients were screened, 1296 were eligible, 334 patients were randomised, 8 were lost to follow-up, therapy compliance was >85%. Clinically meaningful improvement in OKS (between baseline and 1-year) was seen in both arms (p < 0 .001). Between group difference in 1-year OKS was 1.91 (95%CI, −0.17–3.99) points favouring the therapist-led arm (p=0.07). Incorporating all time point data, between group difference in OKS was 2.25 points (95%CI, 0.61–3.90, p=0.008). Small, non-significant reductions (< 5 %) in both worst and average pain scores were observed favouring the therapist-led group. Enhanced satisfaction with pain relief (OR 1.65, p < 0 .02), ability to perform daily functional tasks (OR 1.66, p < 0 .02), and perform heavy functional tasks (OR 1.6, p=0.04) was reported in the therapist-led group. There was a small non-significant difference of 0.02 points (95%CI −0.02–0.06) between groups in EQ-5D, resulting in a £12,125 cost per QALY of delivering the therapist led intervention with a 57% chance of being cost-effective at the standard UK policy threshold of £20,000 per QALY.

TRIO is the largest randomised trial of physiotherapy following TKA, and the first to target rehabilitation to patients at risk of poor outcomes. Both therapist-led and home-exercise based rehabilitation groups made clinically meaningful improvements in outcome by 1-year. We observed a modest difference in OKS in favour of therapist-led rehabilitation compared to the home-exercises which was not statistically significant. The relatively tight confidence intervals suggests that any difference which might exist is too small to be clinically relevant. Patient satisfaction with outcome was however higher in those that received greater physiotherapist contact. While cost per QALY estimates were below UK policy threshold, this result is uncertain and insufficient to make accept-decline recommendations.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_14 | Pages 43 - 43
1 Nov 2018
Beswick AD Strange S Mallon C Lenguerrand E Moore AJ Kunutsor SK Whitehouse MR Porteous A Toms A Blom AW
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Patients with knee prosthetic joint infection (PJI) frequently receive one- or two-stage revision. To explore the feasibility of a randomised controlled trial (RCT) comparing methods, we analysed a UK registry, interviewed patients and surgeons, systematically reviewed literature, held a consensus meeting, and assessed progress of an RCT in hip PJI. In 2014, in England and Wales, knee PJI was treated with one- or two-stage procedures in 19% and 71% of patients respectively. Between 2007 and 2014, use of one-stage procedures doubled and, in major centres, up to 42% of treatments were one-stage. We conducted in-depth interviews with 16 patients with knee PJI and 11 surgeons performing one- or two-stage revision. Patients considered randomisation acceptable with appropriate counselling and, depending on infecting organisms and health status, surgeons would randomise treatments. In meta-analysis, two-year re-infection rates in 10 one-stage series (423 patients) and 108 two-stage series (5,129 patients) were 7.6% (95%CI 3.4,13.1) and 8.8% (7.2,10.6) respectively. In a series of patients with knee PJI, surgeons from 2 major centres considered 6/15 patients eligible for either treatment, with 4 more potentially eligible after treatment of soft tissue infection. In an ongoing RCT of surgical treatment of hip PJI, 116 patients have been randomised at 14 centres in 3 years. Randomising patients with PJI is feasible but, as knee PJI is uncommon, a multicentre RCT would be required. Based on WOMAC score outcome and appropriate assumptions on eligibility and acceptability, 170 patients would need to be randomised over 4 years at 14 major centres.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 25 - 25
1 Oct 2022
Geraghty A Roberts L Hill J Foster N Stuart B Yardley L Hay E Turner D Griffiths G Webley F Durcan L Morgan A Hughes S Bathers S Butler-Walley S Wathall S Mansell G Leigh L Little P
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Background

Internet delivered interventions may provide a route to rapid support for behavioural self-management for low back pain (LBP) that could be widely applied within primary care. Although evidence is emerging that more complex technologies (mobile apps linked to digital wristbands) can have some impact on LBP-related disability, there is a need to determine the effectiveness of highly accessible, web-based support for self-management for LBP.

Methods and results

We conducted a multi-centre pragmatic randomised controlled trial, testing ‘SupportBack’, an accessible internet intervention developed specifically for primary care. We aimed to determine the effectiveness of the SupportBack interventions in reducing LBP-related physical disability in primary care patients. Participants were randomised to 1 of 3 arms: 1) Usual care + internet intervention + physiotherapy telephone support, 2) Usual care + internet intervention, 3) Usual care alone. Utilising a repeated measures design, the primary outcome for the trial was disability over 12 months using the Roland Morris Disability Questionnaire (RMDQ) at 6 weeks, 3, 6 and 12 months. Results: 826 were randomised, with follow-up rates: 6 weeks = 83%; 3 months = 72%; 6 months = 70%; 12 months = 79%. Analysis is ongoing, comparing each intervention arm versus usual care alone. The key results will be presented at the conference.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 46 - 46
2 May 2024
Palmer A Fernquest S Logishetty K Rombach I Harin A Mansour R Dijkstra P Andrade T Dutton S Glyn-Jones S
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The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome.

Two-group parallel, assessor-blinded, pragmatic randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score.

Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001).

Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 104 - 104
4 Apr 2023
Edwards T Khan S Patel A Gupta S Soussi D Liddle A Cobb J Logishetty K
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Evidence supporting the use of virtual reality (VR) training in orthopaedic procedures is rapidly growing. However, the impact of the timing of delivery of this training is yet to be tested. We aimed to investigate whether spaced VR training is more effective than massed VR training.

24 medical students with no hip arthroplasty experience were randomised to learning the direct anterior approach total hip arthroplasty using the same VR simulation, training either once-weekly or once-daily for four sessions. Participants underwent a baseline physical world assessment on a saw bone pelvis. The VR program recorded procedural errors, time, assistive prompts required and hand path length across four sessions. The VR and physical world assessments were repeated at one-week, one-month, and 3 months after the last training session.

Baseline characteristics between the groups were comparable (p > 0.05). The daily group demonstrated faster skills acquisition, reducing the median ± IQR number of procedural errors from 68 ± 67.05 (session one) to 7 ± 9.75 (session four), compared to the weekly group's improvement from 63 ± 27 (session one) to 13 ± 15.75 (session four), p < 0.001. The weekly group error count plateaued remaining at 14 ± 6.75 at one-week, 16.50 ± 16.25 at one-month and 26.45 ± 22 at 3-months, p < 0.05. However, the daily group showed poorer retention with error counts rising to 16 ± 12.25 at one-week, 17.50 ± 23 at one-month and 41.45 ± 26 at 3-months, p<0.01. A similar effect was noted for the number of assistive prompts required, procedural time and hand path length. In the real-world assessment, both groups significantly improved their acetabular component positioning accuracy, and these improvements were equally maintained (p<0.01).

Daily VR training facilitates faster skills acquisition; however weekly practice has superior skills retention.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 20 - 20
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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Purposes of the study and background

Cognitive Functional Therapy (CFT) is a psychologically informed, physiotherapist-led intervention that targets the biopsychosocial complexity of persistent low back pain (LBP). CFT has demonstrated positive outcomes in two randomised controlled trials (RCT) but has not previously been evaluated in the United Kingdom National Health Service (NHS).

This study aimed to determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for people with persistent LBP in the NHS.

Methods and results

A two-arm parallel feasibility RCT compared CFT with UPC in participants with persistent LBP. Data concerning study processes, resources, management and patient reported outcome measures (disability, pain intensity, quality of life and psychosocial function) were collected at baseline, three and six-month follow-up, analysed and evaluated in order to establish feasibility.

Sixty participants (n=30 CFT and n=30 UPC) were recruited with 71.6% (n=43) retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by participants with no safety concerns. The Roland-Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a definitive RCT. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed across outcome measures at six-month follow-up.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 16 - 16
1 Nov 2021
Frydendal T Christensen R Mechlenburg I Mikkelsen LR Overgaard S Ingwersen KG
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Introduction and Objective

Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months.

Materials and Methods

This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 15 - 15
1 Nov 2021
Kayani B Bawwa J Tahmassebi J Fontalis A Wardle N Middleton R Shardlow D Hutchinson J Haddad F
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This study reports the ten-year outcomes of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA).

Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. The outcomes of 262 study patients were analysed at ten years follow-up.

At ten years, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C had increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non- significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up from a clinical score perspective.

The use of UHMWPE was associated with progressively increased annual liner wear rates. At ten years follow-up, this translated to an increased incidence of osteolysis and aseptic loosening requiring revision, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 135 - 135
1 May 2016
Foran J Dennis D Bade M Kim R Miner T Dayton M Struessel T Lapsley J
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INTRODUCTION

Early postoperative strength loss is pronounced following total knee arthroplasty (TKA) and is largely the result of reduced muscular activation. High-intensity progressive rehabilitation may limit postoperative weakness and improve long-term outcomes, but no randomized controlled trials have examined its use after TKA. The purpose of this trial was to examine the efficacy of a high-intensity progressive rehabilitation protocol (HI) compared to a lower intensity (LI) rehabilitation protocol after TKA.

METHODS

One hundred and sixty-two subjects (aged 63±7 years, 89 females) were randomized to either the HI group or LI groups after TKA. The HI intervention consisted of an early initiation of intensive rehabilitation using progressive resistance exercise. The LI intervention was based on a synthesis of previously published standard TKA rehabilitation programs. Both groups were treated 2–3 times per week for 12 weeks. Outcomes included the stair climbing test, timed-up-and-go test, five-times sit-to-stand test, 6-minute walk test, isometric quadriceps and hamstring strength, quadriceps activation, surgical knee range of motion, and WOMAC. Secondary analysis evaluated whether outcomes differed depending on post-operative quadriceps activation. Outcomes were assessed preoperatively and at 1, 2, 3, 6, and 12 months postoperatively.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 13 - 13
11 Apr 2023
Edwards T Gupta S Soussi D Patel A Khan S Liddle A Cobb J Logishetty K
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Current evidence suggests that superior surgical team performance is linked to fewer intra-operative errors, reductions in mortality and even improved patient outcomes. Virtual reality has demonstrated excellent efficacy in training surgeons and scrub nurses individually, however its impact on training teams is currently unknown. This study aimed to assess if training together (scrub nurse and surgeon) in an innovative multiplayer virtual reality program was superior to single player training for novices learning anterior approach total hip arthroplasty (AA-THA).

40 participants (20 novice surgeons (CT1-ST3 level) and 20 novice scrub nurses) were enrolled in this study and randomised to individual or team virtual reality training. Individually-trained participants played with virtual avatar counterparts, whilst teams trained live in pairs (surgeon and scrub nurse). Both groups underwent 5 VR training sessions over 6 weeks. Subsequently, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated operating theatre. Teams performed together and individually-trained participants were randomly paired up with a solo player of the opposite role. Videos of the assessment were marked by two blinded expert assessors. The primary outcome was team performance as graded by the validated NOTECHs II score. Secondary outcomes were procedure time and number of technical errors from an expert pre-defined protocol.

Teams outperformed individually-trained participants for non-technical skills in the real-world assessment (NOTECHS-II score 50.3 ± 6.04 vs 43.90 ± 5.90, p=0.0275). They completed the assessment 28.1% faster (31.22 minutes ±2.02 vs 43.43 ±2.71, p=0.01), and made close to half the number of technical errors when compared to the individual group (12.9 ± 8.3 vs 25.6 ± 6.1, p=0.001).

Multiplayer, team training appears to lead to faster surgery with fewer technical errors and the development of superior non-technical skills.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 7 - 7
16 May 2024
Matthews P Scammell B Ali A Nightingale J Coughlin T Khan T Ollivere B
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Background

Ankle fractures are extremely common but unfortunately, over 20% fail to obtain good to excellent recovery. For those requiring surgical fixation, usual-care post-surgery has included six-weeks cast immobilisation and non-weightbearing. Disuse atrophy and joint stiffness are detrimental sequelae of this management. While rehabilitation, starting at two-weeks post-surgery is viewed as safe, the literature contains methodological flaws and a lack of focus on early exercise, perpetuating the controversy over the effectiveness of early exercise interventions.

Objectives

Our objectives were to determine if following operative fixation for Weber B fracture, the physiotherapy intervention, early motion and directed exercise (EMADE), applied in the clinical setting, were superior to Usual-care at 12-weeks (primary outcome) and 24-weeks.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 32 - 32
1 Dec 2022
Kamikovski I Woodmass J McRae S Lapner P Jong B Marsh J Old J Dubberley J Stranges G MacDonald PB
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Previously, we conducted a multi-center, double-blinded randomized controlled trial comparing arthroscopic Bankart repair with and without remplissage. The end point for the randomized controlled trial was two years post-operative, providing support for the benefits of remplissage in the short term in reducing recurrent instability. The aim of this study was to compare the medium term (3 to 9 years) outcomes of patients previously randomized to have undergone isolated Bankart repair (NO REMP) or Bankart repair with remplissage (REMP) for the management of recurrent anterior glenohumeral instability. The rate of recurrent instability and instances of re-operation were examined.

The original study was a double-blinded, randomized clinical trial with two 1:1 parallel groups with recruitment undertaken between 2011 and 2017. For this medium-term study, participants were reached for a telephone follow-up in 2020 and asked a series of standardized questions regarding ensuing instances of subluxation, dislocation or reoperation that had occurred on their shoulder for which they were randomized. Descriptive statistics were generated for all variables. “Failure” was defined as occurrence of a dislocation. “Recurrent instability” was defined as the participant reporting a dislocation or two or more occurences of subluxation greater than one year post-operative. All analyses were undertaken based on intention-to-treat whereby their data was analyzed based on the group to which they were originally allocated.

One-hundred and eight participants were randomized of which 50 in the NO REMP group and 52 in the REMP group were included in the analyses in the original study. The mean number of months from surgery to final follow-up was 49.3 for the NO REMP group and 53.8 for the REMP group. The rates of re-dislocation or failure were 8% (4/52) in the REMP group at an average of 23.8 months post-operative versus 22% (11/50) in the NO REMP at an average of 16.5 months post-operative. The rates of recurrent instability were 10% (5/52) in the REMP group at an average of 24 months post-operative versus 30% (15/50) in the NO REMP group at an average of 19.5 months post-operative. Survival curves were significantly different favouring REMP in both scenarios.

Arthroscopic Bankart repair combined with remplissage is an effective procedure in the treatment of patients with an engaging Hill-Sachs lesion and minimal glenoid bone loss (<15%). Patients can expect favourable rates of recurrent instability when compared with isolated Bankart repair at medium term follw-up.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 234 - 234
1 Jun 2012
Tai T Yang C Lin C Lai K
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Introduction

Total knee arthroplasty (TKA) is associated with significant blood loss, for which blood transfusion might be necessary. The role of the tourniquet is controversial, though it is widely used by orthopedic surgeons. Its use was believed to be effective in decreasing intraoperative blood loss and creating a bloodless surgical field, which theoretically would facilitate the cementing technique and other surgical procedures. However, reactive blood flow reached its peak within five minutes after the tourniquet had been released. The tourniquet controls intraoperative blood loss, but cannot stop postoperative blood loss. Patients who were managed with a tourniquet during the operation often complained of thigh pain. This was possibly caused by the direct pressure of an inflated tourniquet on the nerves and local soft tissues. Limb swelling and increased soft tissue tension caused by reactive hyperperfusion after tourniquet deflation may also contribute to the wound pain. The aim of our study is to investigate the effect of tourniquet on blood loss and soft tissue damage in TKA.

Materials & Methods

In this prospective, randomized study, 72 patients with primary cemented knee arthroplasty were randomly allocated to two groups (with and without tourniquet). The operation time, blood loss, post-operative hemoglobin, hematocrit, markers of soft tissue damage (myoglobin, Cretine Posphokinase(CK), LDH, GOT, Creatinine), status of rehabilitation, knee pain and thigh pain were monitored until discharge.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 14 - 14
1 Nov 2021
Nicoules S Zaoui A Hage SE Scemama C Langlois J Courpied J Hamadouche M
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The purpose of this study was to compare oxinium versus metal-on-polyethylene wear in two consecutive prospective randomized series of low friction total hip arthroplasty at a minimum 10-year follow-up.

A total of 100 patients with a median age of 60.9 years were randomized to receive either oxinium (50 hips) or metal (50 hips) femoral head. The polyethylene socket was EtO sterilized in the first 50 patients, whereas it was highly cross-linked and remelted (XLPE) in the following 50 patients. The primary criterion for evaluation was linear head penetration measurement using the Martell system by an investigator blinded to the material. Also, a survivorship analysis was performed using wear related loosening revised or not as the end point.

Complete data were available for analysis in 40 hips at a median follow-up of 12.9 years (11 to 14), and in 36 hips at a median follow-up of 12.3 years (10 to 13) in the EtO sterilized and XLPE series, respectively.

In the EtO sterilized series, the mean steady-state wear rate was 0.245 ± 0.080 mm/year in the oxinium group versus 0.186 ± 0.062 mm/year in the metal group (p = 0.009). In the XLPE series, the mean steady-state wear rate was 0.037±0.016 mm/year in the oxinium group versus 0.036±0.015 mm/year in the metal group (p = 0.94). The survival rate at 10 years was 100% in both XLPE series, whereas it was 82.9% (IC 95%, 65–100) and 70.5% (IC95%, 50.1–90.9) in the metal-EtO and oxinium-EtO series, respectively.

This RCT demonstrated that up to 14-year follow-up, wear was significantly reduced when using XLPE, irrespective of the femoral head material. Also, no osteolysis related complication was observed in the XLPE series. In the current study, oxinium femoral heads showed no advantage over metal heads and therefore their continued used should be questioned related to their cost.


Abstract

Introduction

Cementless fixation of Oxford Unicompartmental Knee Replacements (UKRs) is an alternative to cemented fixation, however, it is unknown whether cementless fixation is as good long-term. This study aimed to compare primary and long-term fixation of cemented and cementless Oxford UKRs using radiostereometric analysis (RSA).

Methodology

Twenty-nine patients were randomised to receive cemented or cementless Oxford UKRs and followed for ten years. Differences in primary fixation and long-term fixation of the tibial components (inferred from 0/3/6-month and 6-month/1-year/2-year/5-year/10-year migration, respectively) were analysed using RSA and radiolucencies were assessed on radiographs. Migration rates were determined by linear regression and clinical outcomes measured using the Oxford Knee Score (OKS).


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 103 - 103
1 Mar 2008
Davey J Camazzola D Hammond T
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Sixty-two consecutive primary total hip arthroplasties were prospectively randomized to receive either hydroxyapatite coated (thirty-five hips) or nonhydroxy-apatite coated (twenty-seven hips) femoral prostheses. At a minimum eleven-year followup fifty-one hips (forty-four patients) were evaluated. Only one femoral stem had been revised (secondary to traumatic periprosthetic fracture). Radiographs were available for thirty-nine hips. None of these femoral stems were loose. Harris Hip scores were evaluated for thirty-six unrevised hips and did not differ significantly between the two groups. There appears to be no significant advantage to hydroxyapatite coating for this femoral prosthesis at an average follow-up of thirteen years.

There are a paucity of long term randomized controlled trials on results of hydroxapatite coating of femoral prostheses. The purpose of this study was to update the results of a prospective randomized study of a proximally pourous coated, tapered titanium femoral component with and without hydroxyapatite coating.

Sixty-two consecutive primary total hip arthroplasties done by one surgeon in fifty-five patients were prospectively randomized to receive either hydroxyapatite coated (thirty-five hips) or nonhydroxyapatite coated (twenty-seven hips) femoral prostheses. At a minimum eleven year followup, three hips (three patients) were lost to followup, and a further eight patients had expired (eight hips). The remaining surviving cohort of fifty-one hips (forty-four patients) were evaluated clinically, including Harris Hip Scores, and radiographically.

At an average of thirteen years followup, only one femoral stem had been revised (secondary to traumatic periprosthetic fracture), that being in the hydroxyapatite group. There were eight acetabular revisions in the hydroxyapatite group (thirty-four percent) and four acetabular revisions in the nonhydroxyapatite group (sixteen percent). Radiographs were available for thirty-nine hips. None of these femoral stems were loose. Harris Hip scores were evaluated for thirty-six unrevised hips and did not differ significantly between the two groups.

Using endpoints of femoral revision, radiographic loosening, and Harris Hip Scores there appears to be no significant advantage to hydroxyapatite coating for this femoral prosthesis at an average follow-up of thirteen years.

Funding: Biomet, Warsaw IN


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 6 - 6
1 Aug 2012
Alsousou J Handley R Hulley P Thompson M McNally E Harrison P Willett K
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Purpose

Platelet Rich Plasma (PRP) has been shown to have positive effect in tendon regeneration in in-vitro and limited in-vivo animal studies. We aim to study PRP use in acute Achilles tendon rupture (ATR) regeneration in a purposely designed clinical trial.

Methods

This is a prospective double-arm patient-blinded randomized controlled trial. ATR patients were randomized into PRP treatment or control groups. Non-operatively treated patients received PRP or control injection in clinic. In operatively treated patients, PRP gel was applied in the ruptured gap during percutaneous repair. Standard rehabilitation protocol was used and patients were followed up for 24 weeks. ATR, VISA-A and FAOS scores were used as subjective outcome measures. Functional ultrasound Elastography (FUSE) was performed at each follow-up to assess the mechanical properties of tendons. PRP analysis and tendon needle-biopsy were performed to study the histological differences during healing in both groups.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 85 - 85
1 Apr 2012
Molyneux S Spens H Gibson J
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To compare outcomes and costs of transforaminal endoscopic surgical discectomy (TES) with those of microdiscectomy (Micro)

48 patients with a primary lumbar disc prolapse were randomly allocated by computer to surgery.

Assessments were made of leg and back pain (VAS), Oswestry Disability index (ODI), and SF-36 as primary outcomes. Cost data was collated.

25 TES and 23 Micro patients are reported with similar age, sex, smoking status and affected disc levels (14 v.17 L5/S1). Three months following surgery leg pain scores had decreased by 55 and 65% in the two groups. Patient satisfaction ratings were equal. ODI had decreased 15 points in both groups by 1yr and this improvement was maintained to 2 years (final scores: 7±3 TES v.14±13 Micro - means ±SD; p<0.05). Similar changes were noted in SF36-P. Mean bed stay was lower in the TES group (16 v. 40 hours). Other post-operative costs were similar. There were no immediate complications. One revision was required at 12 months (TES) and one at 18 months (Micro). Two patients presented with a disc prolapse at a different level and side (both TES).

Results at up to two years follow-up are similar following the two interventions. Recovery was more rapid in those patients undergoing endoscopic surgery.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 50 - 50
1 Jul 2022
Fontalis A Kayani B Asokan A Haddad IC Tahmassebi J Konan S Oussedik S Haddad FS
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Abstract

Introduction

The postoperative inflammatory response may be implicated in the aetiology of patient dissatisfaction following Total Knee Arthroplasty. Robotic-arm assisted TKA has been associated with reduced bone and soft tissue trauma. The objective of this Randomised Controlled Trial was to compare the inflammatory response in conventional Jig-based versus robotic arm-assisted TKA and examine the relationship with patient reported outcome measures and functional outcomes.

Methodology

30 patients with knee osteoarthritis were randomised to either conventional or robotic-arm assisted TKA. Blood samples were collected for up to 28 days post-operatively and intraarticular drain samples at 6 and 24 hours, to ascertain the systemic and local inflammatory responses. The Spearman's correlation was utilised to evaluate the relationship with PROMs and functional outcomes.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_9 | Pages 37 - 37
1 May 2018
Ferguson R Broomfield J Malak T Palmer A Whitwell D Taylor A Glyn-Jones S
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Background

Short bone-conserving femoral stem implants were developed to achieve more physiological, proximal bone loading than conventional femoral stems. Concerns have arisen, however, that improved loading may be offset by lower primary stability because of the reduced potential area for bony contact.

Aims

The aim of this study was to determine the primary stability of a novel short femoral stem compared with a conventional femoral stem following cementless total hip arthroplasty (THA), in a prospective, blinded, randomised, controlled trial using radiostereometric analysis.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 50 - 50
1 Apr 2018
Wylde V Artz N Dixon S Marques E Lenguerrand E Blom A Gooberman-Hill R
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Background

Inpatient physiotherapy is routinely provided after total knee replacement (TKR) surgery to enhance recovery prior to discharge. However, the provision of outpatient physiotherapy is variable in the UK, and the longer-term benefits of outpatient physiotherapy are unclear. This study aimed to evaluate the feasibility of conducting a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of group-based outpatient physiotherapy after TKR.

Methods

Patients listed for primary TKR were recruited prior to surgery. Patients who decided not to participate were asked about their reasons for non-participation. Patients were randomised to attend a newly developed post-operative physiotherapy class plus usual care or usual care alone. Patients allocated to the intervention group were invited to attend a weekly one-hour physiotherapy class, starting at 6 weeks after surgery and running over 6 consecutive weeks. The group classes were run by two physiotherapists within an outpatient gym, and involved task-orientated and individualised exercises. Classes ran on a rolling system, allowing new patients to join each week. Participants completed an evaluation questionnaire after the final class. Outcomes assessment was by questionnaire prior to surgery and 2 weeks, 3 months and 6 months after surgery. Outcomes related to function, pain, balance, self-efficacy, participation, quality of life and resource use.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 51 - 51
1 Mar 2021
Larose G McRae S Beaudoin A McCormack R MacDonald P
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There is increasing evidence that patients with ACL reconstruction using ipsilateral graft harvest are at greater risk of rupture (12.5%) on their contralateral compared to their surgical side (7.9%). The purpose of this study is to re-evaluate patients from a previous study comparing ipsi- versus contralateral graft harvest to compare ACL rupture rate at a minimum 10 year follow-up.

An attempt to contact all participants from a previously published study was made to invite them to return for a follow-up. The assessment included an International Knee Documentation Committee Knee Clinical Assessment (IKDC), isokinetic concentric knee flexion and extension strength testing, as well as the ACL-Quality of life (ACL-QOL). A chart review was conducted to identify or confirm subsequent ipsi- or contralateral knee surgeries.

In patients with ipsilateral graft, 3/34 (8.8%) re-ruptured and 3/34 (8.8%) had contralateral rupture. In the contralateral group, 1/28 (3.6%) re-ruptured and 2/28 (7.1%) had contralateral rupture. The relative risk (RR) of re-rupture with ipsilateral graft was 2.47 compared to using the contralateral site (p=0.42). RR of rupture on the contralateral side when ipsilateral graft was used was 1.23 compared to the alternate approach. Current contact information was unavailable for 21 patients. Of the 47 remaining, 37 were consented (79%). No difference in the ACL-QOL between groups (ipsilateral 68.4±24.4, contralateral 80.1±16.0, p=0.17) was observed. There were no differences in knee flexion strength between groups (peak torque flexion affected leg: ipsilateral 77.8nm/kg±27.4, contralateral: 90.0 nm/kg±35.1; p=0.32; Unaffected leg: ipsilateral: 83.3 nm/kg±30.2 contralateral 81.7 nm/kg±24.4; p= 0.89).

This study suggests that using the contralateral hamstring in ACL rupture is not associated with an increase in ACL rupture on either side. The risk of ACL injury was low in all limbs; therefore, a larger study would be required to definitively state that graft side had no impact.


Full Access

This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture.

A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period.

The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction.

Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures.


Greater trochanteric pain syndrome is a painful condition characterised by pain around the greater trochanter usually affecting middle-aged women. The majority of patients will improve with conservative management such as physiotherapy and non-steroidal anti-inflammatory drugs (NSAIDs); however, if this fails then more invasive treatments including corticosteroids and surgery may be required. Platelet-rich plasma (PRP) is an autologous blood product, which has a higher concentration of growth factors postulated to provide enhanced healing and anti-inflammatory properties. The Hip Injections PRP Vs Placebo (HIPPO) trial aims to assess the ability of ultrasound-guided PRP injections to improve symptoms and function in patients with GTPS.

64 patients were enrolled and randomised to either the PRP or placebo (normal saline) treatment arm. Two patients decided to drop out of the trial. Clinical outcomes in both groups were evaluated and compared using the International Hip Outcome Tool-12 (iHOT12), Visual Analogue Scale (VAS) of pain, the modified Harris Hip Score (mHHS) and the presence or absence of complications at 3 and six months. The level of significance was set at p<0.05. Both groups received physiotherapy after the injections.

The mean age was 57.5. There were 6 males and 56 females with M:F ratio of 1:9.3. Both groups were similar in terms of demography and preoperative scores. The iHOT12 score improved from 28.23 to 45.42 at three-months and decreased slightly to 42.44 at six-months in the Placebo group. The iHOT12 in the PRP group improved from 35.51 to 44.47 at three-months and decreased to 39.78 at six-months. Both groups showed improved VAS and mHHS at three-months compared to the baseline with no statistically significant difference between the two groups (p >0.05). The scores decreased at six-months however remained above the baseline. No complications were reported. Gender and age had no effect on outcomes.

Both groups similarly improved from baseline. Physiotherapy can be considered as an important factor in patients' treatment. Further research should be conducted to investigate the role of physiotherapy in the treatment of GTPS.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 27 - 27
1 Jan 2018
Zaoui A Langlois J El Hage S Scemama C Courpied J Hamadouche M
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The purpose of this study was to compare the effect of femoral head material (delta ceramic versus metal) on polyethylene wear in a consecutive prospective randomized series of low friction total hip arthroplasty.

A total of 110 patients with a mean age of 60.6 ± 9.3 (34–75) years were randomized (power of 90%, alpha of 5%) to receive either a metal (55 hips) or a delta ceramic (55 hips) femoral head. The polyethylene socket was moderately cross-linked (3 Mrads of gamma radiation in nitrogen) and annealed at 130°C in all hips. All other parameters were identical in both groups. The primary criterion for evaluation was linear head penetration measurement using the Martell system, performed by an investigator blinded to the material of the femoral head. Creep and steady state wear values were calculated.

At the minimum of 3-year follow-up, complete data were available for analysis in 38 hips at a median follow-up of 4.4 years (3.0 to 5.7), and in 42 hips at a median follow-up of 4.0 years (3.0 to 5.4) in the metal and delta ceramic groups, respectively. The mean creep, measured as the linear head penetration at one year follow-up, was 0.42 ± 1.0 mm in the metal group versus 0.30 ± 0.81 mm in the delta ceramic group (Mann and Whitney test, p = 0.56). The mean steady state penetration rate from one year onwards measured 0.17 ± 0.44 mm/year (median 0.072) in the metal group versus 0.074 ± 0.44 mm/year (median 0.072) in the delta ceramic group (Mann and Whitney test, p = 0.48). No case of delta ceramic femoral head fracture was recorded, and no hip had signs of periprosthetic osteolysis.

This study demonstrated that up to 5-year follow-up, delta ceramic femoral head did not significantly influence creep neither wear of a contemporary annealed polyethylene. Longer follow-up is necessary to further evaluate the potential clinical benefits of delta ceramic.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 327 - 327
1 Jul 2008
Hanusch BC Patil S Hui A Gregg P
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The aim of this study was to determine whether there is a difference in the functional outcome between fixed and mobile bearings in total knee arthroplasty.

120 patients were randomized (computer generated) to receive either a fixed or mobile bearing P.F.C. Sigma total knee replacement. 96 patients were needed to detect a 20° difference in range of motion (ROM) with a significance level of 0.05 and a test power of 0.97. Oxford knee score (OKS) and ROM were assessed independently before and one year after surgery.

Mean ROM and Oxford knee score before and at one year after surgery for both groups are shown as preliminary results for 70 patients (follow-up expected to be completed by March 2006):

There is no statistically significant difference in the mean ROM at one year and in change in ROM between the two groups (p=0.53 and p=0.21 respectively). The findings were similar for Oxford Knee Score at one year and change in Oxford Knee Score (p=0.45 and p=0.82). There was no early aseptic loosening in either group.

The one year results suggest that there is no significant difference in functional outcome measured as ROM and Oxford Knee Score between the two types of bearing. Further follow-up will be carried out to detect any differences in the long term outcome.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 141 - 141
1 Mar 2008
Nguyen D Ferreira L Brownhill J Kedgley A Macdermid J King G Drosdowech D Johnson J Faber K Garvin G Mozzon J
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Purpose: Glenoid replacement remains challenging due to the difficult visualization of anatomical reference landmarks and highly variable version angles. Improper positioning of the glenoid component leads to loosening, early wear, and instability. The objective of this study was to develop and evaluate a tracking system for glenoid implantation. We hypothesized that Computer Assisted Glenoid Implantation (CAGI) would achieve a more accurate and reliable placement of the glenoid component compared to traditional methods.

Methods: 3D CT models of sixteen paired cadaveric shoulder specimens were reconstructed and angles were measured using 3D modeling softwares. Jigs were developed to track instruments and to correct for scapular motion. A standardized protocol for determining in real-time via electromagnetic tracking the glenoid centre, version, inclination and ultimate component placement was previously developed and validated in our laboratory. Specimens were randomized to either traditional or CAGI performed by one of two blinded fellowship trained shoulder surgeons. The mean age was 67 years (range 61–88). Native version and inclination were similar in both groups. All phases of glenoid implantation were navigated.

Results: CAGI was more accurate in achieving the correct version during all phases of glenoid implantation (p < 0.05; paired t-test). CAGI CONTROL Initial pin * 6.3 ± 2.9° Reaming *7.0 ± 3.9° Post drilling * 0.6 ± 0.4° 8.3 ± 4.6°|Post cement * 2.3 ± 2.0° 7.9 ± 3.6°|Post implant CT * 1.8 ± 0.9° 7.7 ± 4.0°. Table 1. Absolute values of the mean error ± SD of version angles obtained with either CAGI or the traditional method (goal = 0° version; * p < 0.05). The largest errors with traditional were observed during drilling and reaming where visualization was especially obscured by the reamer heads. The trend was to retrovert the glenoid. There was no difference with respect to inclination angles (p > 0.05).

Conclusions: Preoperative planning using CT imaging with 3D modeling and intra-operative tracking were combined to produce improved accuracy and reliability of glenoid implantation.

Funding : Other Education Grant

Funding Parties : National Sciences & Engineering Research Council research grant


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 121 - 121
1 May 2016
Kosse N Heesterbeek P Schimmel J Van Hellemondt G Wymenga A Defoort K
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Background

To improve implant positioning in total knee arthroplasty (TKA) patient-specific instrumentation (PSI) has been introduced as alternative for conventional instrumentation (CI). Though the PSI technique offers interesting opportunities in TKA, there is no consensus about the effectiveness of PSI in comparison with CI and results concerning soft-tissue balancing remain unclear. Therefore, the primary aim of the present study was to investigate the varus-valgus laxity in extension and flexion in patients receiving a TKA using PSI compared with CI. Additionally, radiological, clinical and functional outcomes were assessed.

Methods

In this prospective randomization controlled trial, 42 patients with osteoarthritis received a Genesis II PS (Smith & Nephew, Memphis, Tennessee), with either PSI (Visionaire, Smith & Nephew) or CI (Smith & Nephew). Patients visited the hospital preoperative and postoperative after 6 weeks, 3 and 12 months. One-year postoperative varus-valgus laxity was measured in extension and flexion on stress radiographs. Additional assessments included: the hip-knee-ankle angle on long-leg radiographs, femoral and tibia component rotation on CT-scans, radiolucency, the Knee Society Score (KSS), VAS pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score (KOOS), Patella score (Kujala), the University of California Los Angeles activity score (UCLA), the anterior-posterior laxity in 20° and 90° knee flexion, adverse events and complications. The outcome measures were compared using independent t-tests, non-parametric alternatives and repeated measurements, with a significance level of p<0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 25 - 25
1 Oct 2018
Geller JA Sarpong NO Grosso M Lakra A Jennings E Heller MS Shah RP Cooper HJ
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Introduction

The success of total knee arthroplasty (TKA) necessitates precise osteotomies and soft tissue balancing to realign the lower extremity to a neutral mechanical axis. While technological advances have facilitated precise osteotomies, soft tissue balancing has traditionally relied mostly on surgeons’ subjective and variable tactile feedback. As soft tissue imbalance accounts for 35% of early TKA revisions in North America, we aimed to compare outcomes when TKA was balanced free-hand versus a sensor-guided balancing device (VERASENSE, OrthoSensor, Inc (Dania, FL)).

Methods

In a randomized-controlled fashion, patients underwent primary TKA soft tissue balancing either free-hand or with VERASENSE (Orthosensor Inc, Dania FL) at our institution beginning January 2018. With VERASENSE, soft-tissue balancing is considered when the pressure difference between the medial and lateral knee compartments was less than 15 pounds. Data regarding patient-reported outcomes, knee range of motion (ROM), pain level, opioid consumption, inpatient ambulation distance, length of stay (LOS), and incidence of arthrofibrosis was collected and analyzed in a two-year minimum follow-up and target patient goal of 120 patients.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 25 - 25
1 Oct 2020
Kayani B Tahmassebi J Ayuob A Konan S Oussedik S Haddad FS
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Introduction

The objectives of this study were to compare the systemic inflammatory reaction, localised thermal response and macroscopic soft tissue injury outcomes in conventional jig-based total knee arthroplasty (conventional TKA) versus robotic total knee arthroplasty (robotic TKA).

Methods

This prospective randomised controlled trial included 30 patients with symptomatic knee osteoarthritis undergoing conventional TKA versus robotic TKA. Predefined serum markers of inflammation and localised knee temperature were collected preoperatively and postoperatively at 6 hours, day 1, day 2, day 7, and day 28 following TKA. Blinded observers used the Macroscopic Soft Tissue Injury (MASTI) classification system to grade intraoperative periarticular soft tissue injury and bone trauma. Plain radiographs were used to assess the accuracy of achieving the planned limb alignment and implant positioning in both treatment groups.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 55 - 55
1 Sep 2012
Bourke M Dalton P FitzPatrick P Buttrum P Jull G Russell T
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The medial parapatellar approach in total knee arthroplasty is arguably the most common approach, but the subvastus approach is less insulting to the quadriceps mechanism.

A single centre, randomized controlled trial was conducted in a metropolitan hospital to investigate whether the subvastus approach afforded better outcomes than the medial parapatellar approach. Ninety participants with knee osteoarthritis were randomized to either the subvastus or medial parapatellar approach. The primary outcome was the American Knee Society Score and secondary outcomes reported included pain, extension and flexion range of motion, quadriceps lag, girth, Oxford Knee Score, 3 meter timed up and go test, days to straight leg raise, surgeon perceived difficulty, operation duration, tourniquet duration and length of stay. Data were collected preoperatively, intra-operatively, days 1,2,3, discharge, 6 weeks and 6, 12 and 18 months post operatively.

Analysis was undertaken on 76 participants revealing no significant difference with the primary outcome (p=0.076; MP 167.3±36.6; SV 153.1±36.6) or any other outcome except for surgeon perceived difficulty, which favored the medial parapatellar approach (p=0.001; MP 3.3/10±1.9; SV 5.4/10±2.3) and days to straight leg raise, which favoured the subvastus approach by 0.9 days (p=0.044; MP 2.8±1.9; SV 1.9±1.6).

The subvastus approach is technically more difficulty and offers no clinical benefit over the medial parapatellar approach.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 58 - 58
1 Sep 2012
Young S Vince K Coleman B
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Despite modern surgical techniques, reported rates of deep infection following Total Knee Replacement (TKR) persist between 1–2.5%. Coagulase-negative staphylococcus (CNS) has become the most common causative organism, and while growth of CNS is more indolent thanstaphylococcus aureus, it has a relatively higher minimum inhibitory concentration (MIC) against cephalosporins. Tissue concentrations of prophylactic antibiotics may fall below this level during TKR with conventional ‘systemic’ dosing.

Regional administration of prophylactic antibiotics via a foot vein following tourniquet inflation has been shown to provide tissue concentrations approximately 10 times higher than systemic dosing, however cannulation of a foot vein is difficult, time consuming, and may compromise sterility.

Intraosseous cannulation offers an alternative method of accessing the vascular system, and the aim of this study was to assess its effectiveness in administration of prophylactic antibiotics. 22 patients undergoing primary total knee arthroplasty were randomised into two groups. Group 1 received 1g of cephazolin systemically 10 minutes prior to tourniquet inflation. In Group 2 the EZ-IO tibial cannulation system was used, and 1g of cephazolin was administered intraosseously in 200ml of normal saline following tourniquet inflation and prior to skin incision. Subcutaneous fat and femoral bone samples were taken at set intervals during the procedure, and antibiotic concentrations measured using High Performance Liquid Chromatography (HPLC).

There were no significant differences in patient demographics, comorbidities, or physical parameters between groups. The overall mean tissue concentration of cephazolin in subcutaneous fat was 185.9μg/g in the intraosseous group and 10.6μg/g in the systemic group (p<0.01). The mean tissue concentration in bone was 129.9 μg/g in the intraosseous group and 11.4μg/g in the systemic group (p<0.01). These differences were consistent across all sample time points throughout the procedure. No complications occurred in either group.

Intraosseous regional administration can achieve tissue levels of antibiotic over an order of magnitude higher than systemic administration. Further work is required to determine if there is clinical benefit in preventing infection, particularly against CNS. This novel mode of drug administration may also have other applications, allowing ‘surgical site delivery’ of medication while minimising systemic side effects.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 110 - 110
1 Sep 2012
Nikolaou V Edwards M Bogoch E Schemitsch E Waddell J
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This prospective randomised controlled trial aims to compare the clinical and radiological outcomes of ceramic on ceramic, cobalt chrome on ultra-high molecular weight polyethylene, and cobalt chrome on highly cross-linked polyethylene bearing surfaces at a minimum of five years.

One hundred and two primary total hip replacements were performed in ninety one patients between February 2003 and March 2005. All patients were younger than 65 (mean 52.7, 19–64). They were randomised to receive one of the three bearing surfaces. All patients had 28mm articulations with a Reflection uncemented acetabular component and a Synergy stem (Smith & Nephew, Memphis, Tennessee). Patients were followed up periodically up to at least sixty months following surgery. Outcome measures included WOMAC and SF12 scores. Radiological assessment included implant position, evidence of osteolysis and measurement of linear wear.

Ninety seven hip replacements in eighty seven patients were available for review at a minimum of five years. Two hips were revised (one for infection and one for periprosthetic fracture), leaving a total of ninety four hips available for final review. There were no differences in age, gender, body mass index, diagnosis, level of activity, and co-morbidities between the three groups. At a minimum of five years there were no statistical differences in the clinical outcomes using the WOMAC or SF12 scores. Three patients in the ceramic group reported squeaking. Radiological evaluation revealed mean annual wear rates in the ceramic group of 0.006mm/yr, standard polyethylene of 0.151mm/yr and highly cross linked polyethylene of 0.059mm/yr. ANOVA analysis revealed these differences in wear rates to be significant (p<0.0001).

In the mid term there are no differences in clinical outcome between ceramic on ceramic, cobalt chrome on ultra-high molecular weight polyethylene, and cobalt chrome on highly cross-linked polyethylene bearing surfaces in total hip arthroplasty. Ultra high molecular weight polyethylene has a significantly greater annual linear wear rate than highly cross-linked polyethylene.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 173 - 173
1 Jun 2012
Waddell J Nikolaou V Edwards M Bogoch E Schemitsch E
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Aim

This prospective randomised controlled trial aims to compare the clinical and radiological outcomes of ceramic on ceramic, cobalt chrome on ultra-high molecular weight polyethylene, and cobalt chrome on highly cross-linked polyethylene bearing surfaces at a minimum of five years.

Methods

One hundred and two primary total hip replacements were performed in ninety one patients between February 2003 and March 2005. All patients were younger than 65 (mean 52.7, 19-64). They were randomised to receive one of the three bearing surfaces. All patients had 28mm articulations with a Reflection uncemented acetabular component and a Synergy stem (Smith & Nephew, Memphis, Tennessee). Patients were followed up periodically up to at least sixty months following surgery. Outcome measures included WOMAC and SF12 scores. Radiological assessment included implant position, evidence of osteolysis and measurement of linear wear.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 63 - 63
19 Aug 2024
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A
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Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in a thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA.

96 candidates for uncemented THA were randomly allocated to either the largest possible metal head (36–44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration (PHP) measured with model-based radiostereometric analysis (RSA). Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The mid-term results of the trial at 5 years are presented.

Median total PHP (interquartile range) was -0.04 mm (−0.12 to 0.02) in the intervention group and -0.03 mm (=0.14 to 0.05) in the control group (p=0.691). The rates of periacetabular radiolucencies were 1/44 and 4/42 (p=0.197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median UCLA rank 7 vs 6, p=0.020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1).

Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 68 - 68
1 Dec 2022
Hoit G Chahal J Whelan DB Theodoropoulos JS Ajrawat P Betsch M Docter S Dwyer T
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The aim of the this study was to determine the effect of the knee flexion angle (KFA) during tibial anterior cruciate ligament (ACL) graft fixation on patient reported outcomes, graft stability, extension loss and re-operation following anatomic single-bundle ACL reconstruction.

All 169 included patients (mean age 28.5 years, 65% male) were treated with anatomic single bundle ACL reconstruction using patellar tendon autograft and randomized to tibial fixation of the ACL graft at either 0o (n=85) or 30o (n=84). The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) two years following surgery. Secondary outcomes were the Marx Activity Scale (MAS), the rate of re-operation, and physical exam findings at one year including KT-1000 and side to side differences in knee extension.

The follow-up rate was 82% (n=139) for the primary outcome. Graft failure rate at two years was 1% (n=2, 1 per group). ACL tibial graft fixation at 0o or 30o did not have a significant effect on KOOS scores at two years following ACLR. Patients whose graft was fixed at a knee flexion angle of 0o had greater scores on the Marx Activity Scale (mean 9.6 [95%CI 8.5-10.6] versus 8.0 [95%CI 6.9-9.1, p=0.04) and a greater proportion of patients who achieved the minimal clinical important difference (MCID) for the KOOS pain subscale (94% vs 81%, p=0.04). There was no significant difference in knee extension loss, KT-1000 measurements or re-operation between the two groups.

In the setting of anatomic single-bundle ACLR using patellar tendon autograft and anteromedial portal femoral drilling, there was no difference in KOOS scores among patients fixed at 0o and 30o. Patient fixed in full extension did demonstrate higher activity scores at 2 years following surgery and a greater likelihood of achieving the MCID for KOOS pain.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 34 - 34
1 Mar 2021
MacDonald P Woodmass J McRae S Verhulst F Lapner P
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Management of the pathologic long-head biceps tendon remains controversial. Biceps tenotomy is a simple intervention but may result in visible deformity and subjective cramping. Comparatively, biceps tenodesis is technically challenging, and has increased operative times, and a more prolonged recovery. The purpose of this study was to determine the incidence of popeye deformity following biceps tenotomy versus tenodesis, identify predictors for developing a deformity, and compare subjective and objective outcomes between those that have one and those that do not.

Data for this study were collected as part of a randomized clinical trial comparing tenodesis versus tenotomy in the treatment of lesions of the long head of biceps tendon. Patients 18 years of age or older with an arthroscopy confirmed biceps lesion were randomized to one of these two techniques. The primary outcome measure for this sub-study was the rate of a popeye deformity at 24-months post-operative as determined by an evaluator blinded to group allocation. Secondary outcomes were patient reported presence/absence of a popeye deformity, satisfaction with the appearance of their arm, as well as pain and cramping on a VAS. Isometric elbow flexion and supination strength were also measured. Interrater reliability (Cohen's kappa) was calculated between patient and evaluator on the presence of a deformity, and logistic regression was used to identify predictors of its occurrence. Linear regression was performed to identify if age, gender, or BMI were predictive of satisfaction in appearance if a deformity was present.

Fifty-six participants were randomly assigned to each group of which 42 in the tenodesis group and 45 in the tenotomy group completed a 24-month follow-up. The incidence of popeye deformity was 9.5% (4/42) in the tenodesis group and 33% (15/45) in the tenotomy group (18 male, 1 female) with a relative risk of 3.5 (p=0.016). There was strong interrater agreement between evaluator and patient perceived deformity (kappa=0.636; p<0.001). Gender tended towards being a significant predictor of having a popeye with males having 6.6 greater odds (p=0.090). BMI also tended towards significance with lower BMI predictive of popeye deformity (OR 1.21; p=0.051). Age was not predictive (p=0.191). Mean (SD) satisfaction score regarding the appearance of their popeye deformity was 7.3 (2.6). Age was a significant predictor, with lower age associated with decreased satisfaction (F=14.951, adjusted r2=0.582, p=0.004), but there was no association with gender (p=0.083) or BMI (p=0.949). There were no differences in pain, cramping, or strength between those who had a popeye deformity and those who did not.

The risk of developing a popeye deformity was 3.5 times higher after tenotomy compared to tenodesis. Male gender and lower BMI tended towards being predictive of having a deformity; however, those with a high BMI may have had popeye deformities that were not as visually apparent to an examiner as those with a lower BMI. Younger patients were significantly less satisfied with a deformity despite no difference in functional outcomes at 24 months. Thus, biceps tenodesis may be favored in younger patients with low BMI to mitigate the risk of an unsatisfactory popeye deformity.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 4 - 4
1 Apr 2018
Western L Logishetty K Morgan R Cobb J Auvinet E
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Background

Accurate implant orientation is associated with improved outcomes after artificial joint replacement. We investigated if a novel augmented-reality (AR) platform (with live feedback) could train novice surgeons to orientate an acetabular implant as effectively as conventional training (CT).

Methods

Twenty-four novice surgeons (pre-registration level medical students) voluntarily participated in this trial. Baseline demographics, data on exposure to hip arthroplasty, and baseline performance in orientating an acetabular implant to six patient-specific values on a phantom pelvis, were collected prior to training. Participants were randomised to a training session either using a novel AR headset platform or receiving one-on-one tuition from a hip surgeon (CT). After training, they were asked to perform the six orientation tasks again. The solid-angle error in degrees between the planned and achieved orientations was measured using a head-mounted navigation system.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 304 - 304
1 Jul 2011
Holubowycz O Howie D Middleton R
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Background: Our multi-centre international randomized controlled trial compared the one-year incidence of dislocation between a 36 mm and 28 mm metal on highly cross-linked polyethylene articulation in primary and revision total hip replacement (THR).

Patients: 644 patients were entered into the study. Surgical approach was posterior in primary THR and posterior, transfemoral or transtrochanteric in revision THR. Patients were stratified according to a number of factors which may influence dislocation risk and polyethylene wear. Patients were randomized intra-operatively to either a 28 or 36 mm articulation.

Results: The 12-month incidence of dislocation was statistically significantly lower in patients undergoing THR with a 36 mm articulation than in those with a 28 mm articulation (1.3% vs 5.4%, p=.004). When primary and revision THR were examined separately, the 12-month incidence of dislocation was statistically significantly lower in patients undergoing primary THR with a 36 mm articulation than in those with a 28 mm articulation (0.8% vs 4.4%, p=.007). Of the 12 primary THR patients with a 28 mm articulation who dislocated within one year, four experienced recurrent dislocation and two were revised for dislocation. Two patients with a 36 mm articulation dislocated, one of whom experienced recurrent dislocation and was revised. The incidence of dislocation after revision THR with a 36 mm articulation was 4.9%, compared to 12.2% with a 28 mm articulation. Three of the five patients who dislocated following revision THR with a 28 mm articulation experienced recurrent dislocation and were revised within one year of surgery. Two patients dislocated following revision THR with a 36 mm articulation but neither experienced recurrent dislocation or further revision.

This large randomized study unequivocally shows for the first time that, compared to a 28 mm articulation, a 36 mm articulation in THR is efficacious in reducing the incidence of dislocation in the first year following THR.