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Bone & Joint Open
Vol. 5, Issue 1 | Pages 20 - 27
17 Jan 2024
Turgeon TR Vasarhelyi E Howard J Teeter M Righolt CH Gascoyne T Bohm E

Aims

A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis.

Methods

Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 77 - 77
10 Feb 2023
Hooper G Thompson D Lash N Sharr J Faulkner D Frampton C Gilchrist N
Full Access

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 BMDMethods: 119 patients were randomised to receive either a proximally coated dual taper wedge stem, a proximally coated anatomic stem or a fully coated collarless triple tapered stem. All surgeries were performed via the posterior approach with mobilization on the day of surgery. 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 and compared to the unoperated contralateral femur as a control. Patient reported outcome measures of pain, function and health were also included at these corresponding follow-ups.

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% inthe 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.

This study demonstrated maintenance of femoral BMD in three different cementless femoral stem designs, with all achieving excellent improvements in patient reported outcomes. 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. 102-B, Issue SUPP_10 | Pages 32 - 32
1 Oct 2020
Yang J Terhune EB DeBenedetti A Della Valle CJ Gerlinger TL Levine BR Nam D
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Introduction

Wound complications following revision total hip arthroplasty (THA) are associated with an increased risk of superficial and deep infections. Closed incision negative-pressure therapy (ciNPT) has been reported to decrease this risk. This study's purpose was to assess if ciNPT decreases the rate of wound complications following revision THA versus a conventional, silver-impregnated dressing.

Methods

This was a single center, randomized controlled trial of patients undergoing both septic and aseptic revision THA. Patients received either ciNPT or a silver-impregnated dressing (control) for 7 days. Wound complications within 90 days of the procedure were recorded, including: surgical site infection (SSI), periprosthetic joint infection (PJI), prolonged drainage greater than 5 days, erythema requiring antibiotics, and hematoma formation. An a priori power analysis determined 201 patients per cohort were necessary to demonstrate a 10% decrease in wound complication rate.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 21 - 21
1 Mar 2021
Gottschalk M Dawes A Farley K Nazzal E Campbell C Spencer C Daly C Wagner E
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Perioperative glucocorticoids have been used as a successful non-opioid analgesic adjunct for various orthopaedic procedures. Here we describe an ongoing randomized control trial assessing the efficacy of a post-operative methylprednisolone taper course on immediate post-operative pain and function following surgical distal radius fixation. We hypothesize that a post-operative methylprednisolone taper course following distal radius fracture fixation will lead to improved patient pain and function.

This study is a randomized control trial (NCT03661645) of a group of patients treated surgically for distal radius fractures. Patients were randomly assigned at the time of surgery to receive intraoperative dexamethasone only or intraoperative dexamethasone followed by a 6-day oral methylprednisolone (Medrol) taper course. All patients received the same standardized perioperative pain management protocol. A pain journal was used to record visual analog pain scores (VAS-pain), VAS-nausea, and number of opioid tablets consumed during the first 7 post-operative days (POD). Patients were seen at 2-weeks, 6-weeks, and 12-weeks post-operatively for clinical evaluation and collection of patient reported outcomes (Disabilities of the Arm, Shoulder and Hand Score [qDASH]). Differences in categorical variables were assessed with χ2 or Fischer's exact tests. T-tests or Mann-Whitney-U tests were used to compare continuous data.

Forty-three patients were enrolled from October 2018 to October 2019. 20 patients have been assigned to the control group and 23 patients have been assigned to the treatment group. There were no differences in age (p=0.7259), Body Mass Index (p=0.361), race (p=0.5605), smoking status (p=0.0844), or pre-operative narcotic use (p=0.2276) between cohorts. 83.7% (n=36) of patients were female and the median age was 56.9 years. No differences were seen in pre-operative qDASH (p=0.2359) or pre-operative PRWE (p=0.2329) between groups. In the 7 days following surgery, patients in the control group took an average of 16.3 (±12.02) opioid tablets, while those in the treatment group took an average of 8.71 (±7.61) tablets (p=0.0270). We see that significant difference in Opioid consumption is formed at postoperative day two between the two groups with patients in the control group taking. Patient pain scores decreased uniformly in both groups to post-operative day 7. Patient pain was not statistically from POD0 to POD2 (p=0.0662 to 0.2923). However, from POD4 to POD7 patients receiving the methylprednisolone taper course reported decreased pain (p=0.0021 to 0.0497). There was no difference in qDASH score improvement at 6 or 12 weeks. Additionally, no differences were seen for wrist motion improvement at 6 or 12 weeks.

A methylprednisolone taper course shows promise in reducing acute pain in the immediate post-operative period following distal radius fixation. Furthermore, although no statistically significant reductions in post-operative opioid utilization were noted, current trends may become statistically significant as the study continues. No improvements were seen in wrist motion or qDASH and continued enrollment of patients in this clinical trial will further elucidate the role of methylprednisolone for these outcomes.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 56 - 56
1 Oct 2020
Lombardi AV Berend KR Huddleston J Crawford D Peters C VanAndel D Anderson M DeHaan A Southgate R Duwelius PJ
Full Access

Background

The purpose of this study is to evaluate the early outcomes with the use of a smartphone-based exercise and educational platform after primary total hip arthroplasty 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 hip arthroplasty (THA). Patients randomized to the control group (198 patients) received the respective institution's standard of care. Those randomized to mymobility treatment group (167 patients) were provided an Apple Watch and mymobility smartphone application. The application provides pre and postoperative educational content, video directed exercise programs as well as tracks the patient's activity. Patients in the treatment group were not initially prescribed physical therapy, but could be if their surgeon deemed it necessary. Early outcomes assessed included 90-day hip range of motion, HOOS JR scores, 30-day single leg stance (SLS) and time up and go (TUG) test.

We also evaluated PT utilization, THA complications associated with readmissions, ER visits not associated with readmissions, urgent care (non standard of care) visits, and physician office visits.

Outcome scores include HOOS-Jr, EQ-5D-5L, single stance (SLS), Timed up and go (TUG).

Satisfaction scores for the procedure and the mymobility study group were also recorded.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 1 - 1
1 Apr 2022
Karayiannis P Agus A Bryce L Hill J Beverland D
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Tranexamic Acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomised control trial aimed to assess if an additional 24 hours of TXA post – operatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date this trial included high risk patients. This paper presents the results of a cost analysis undertaken alongside this RTC.

TRAC-24 was a prospective randomised controlled trial on patients undergoing TKA and THA. Three groups were included, Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour post-operative oral regime, group 2 received only the perioperative dose and group 3 did not receive TXA. Cost analysis was performed out to day 90.

Group 1 was associated with the lowest mean total costs, followed by group 2 and then group 3. The difference between groups 1 and 3 −£797.77 (95% CI −1478.22, −117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in groups 1 and 2 resulted from reduced length of stay, readmission rates, Accident and Emergency (A&E) attendances and blood transfusions.

This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 28 - 28
1 Jul 2020
Corten K Vanbiervliet J Vandeputte F
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INTRODUCTION

The capsular releasing sequence is crucial to safely conduct the Direct Anterior Approach for THA on a regular OR table. The release of the anterior capsule is the first step of the releasing sequence and allows for optimal exposure. This can be done by either resecting a part of the anterior capsule or by preserving it. Our zero hypothesis was that clinical outcomes would not be different between both techniques.

MATERIALS & METHODS

190 Patients operated between November 2017 and May 2018, met the inclusion criteria and were randomly allocated in a double blinded study to either the capsular resection (CR)(N=99) or capsular preservation (CP)(N=91) cohort. The same cementless implant was used in all cases. Patient-reported outcome measures (PROMS) were collected pre- and post-operatively at 6 weeks, 3 months and 1 year. Adverse events were recorded. Outcomes were compared with the Mann-Withney U test and a significance level of p<0,05.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 61 - 61
1 May 2012
F. T M. W
Full Access

Introduction

The treatment of displaced femoral neck fractures in elderly patients is under debate. Hemiarthroplasty is a recognised treatment for elderly patients with reduced capacity for mobilisation. Controversy exists around cemented or uncemented implants for hemiarthroplasty in this population. The aim of this study is to investigate outcomes of cemented vs uncemented hemiarthroplasty implants to two years post operation.

Methods

All elderly patients presenting to one institution with a displaced subcapital neck of femur fracture were offered inclusion. One hundred and sixty patients (mean age, 85 years) with acute displaced femoral neck fractures were randomly allocated to be treated with cemented Exeter, or uncemented Zweymüller Alloclassic Hemiarthroplasty. Clinical and radiologic follow-up to two years with the main outcome measurements being pain, mortality, mobility, complications, reoperations, and quality of life using validated scores recorded by a blinded outcome assessor.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_7 | Pages 1 - 1
1 May 2019
Nicholson J Clement N Goudie E Robinson C
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The primary aim of this study was to undertake a cost-effectiveness analysis (CEA) of acute fixation versus conservative management of displaced midshaft clavicle fractures. The secondary aim was to conduct a sensitivity analysis of patient characteristics that may influence a threshold of £20,000 per quality-adjusted life year gained (QALY).

A CEA was conducted from a randomised control trial comparing conservative management (n=92) to acute plate fixation (n=86) of displaced midshaft clavicle fractures. The incremental cost effectiveness ratio (ICER) was used to express the cost per QALY. The short form 6-dimensional (SF-6D) score was the preference based index to calculate the cost per QALY.

The 12-month SF-6D advantage of acute fixation over conservative management was 0.0085 (p=0.464) with a mean cost difference of £4,096.22 and resultant ICER of £481,908.24/QALY. For a threshold of £20,000/QALY the benefit of acute fixation would need to be present for 24.1 years. Linear regression analysis identified nonunion as the only independent factor to influence the SF-6D at 12-months (p<0.001). Conservatively managed fractures that resulted in a nonunion (n=16) had a significantly worse SF-6D compared to acute fixation (0.0723, p=0.001) with comparable healthcare cost at 12-months (£170.12 difference). Modelling the ICER of acute fixation against those complicated by a nonunion proved to be cost effective at £2,352.97/QALY at 12-months.

Routine plate fixation of displaced midshaft clavicle fractures is not cost-effective. Patients with nonunion after conservative management have increased morbidity with comparable expense to those undergoing acute fixation which suggests targeting these patients is a more cost-effective strategy.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 83 - 83
1 Nov 2018
Flynn S O'Reilly M Feeley I Sheehan E
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Knee osteoarthritis is a common, debilitating condition. Intra articular corticosteroid injections are a commonly used non-operative treatment strategy. Intra articular hip injection with Ketorolac (an NSAID) has proven to be as efficacious as corticosteroids. No prior study compares the efficacy of Ketorolac relative to corticosteroids for relief of discomfort in knee osteoarthritis. The study design was a single centre double blinded RCT. Severity of osteoarthritic changes were graded on plain film weightbearing radiographs using the Kellgren and Lawrence system. Injection was with either 30mg Ketorolac or 40mg Methylprednisolone, given by intra-articular injection, in a syringe with 5mls 0.5% Marcaine. Pre-injection clinical outcomes were assessed using the Numerical Pain Score (NPS), WOMAC, and Oxford knee scores. Patients' NPS scores were assessed at Day 1 and Day 14 post-injection. An assessment of all clinical outcomes took place in clinic at six weeks. There were 72 participants (83 knees) in the study. No patients were lost to follow-up. Mean age was 62.66 years (Range 29–85). 42 knees received a corticosteroid injection, 41 a NSAID injection. Mean Kellgren and Lawrence score was 3.1. There was no significant difference in pre-injection clinical scores in either group. There was a significant improvement of NPS on Day 1 and 14 in both injection groups(p<0.05). These improved pain scores were sustained at 6 weeks in both groups. WOMAC and Oxford Knee Scores showed a statistically significant improvement in the corticosteroid group. WOMAC scores showed significant improvement in the NSAID group, however these improvements didn't achieve statistical significance using the Oxford Knee Score. Corticosteroid or NSAID injectate are a safe and effective non-operative treatment strategy in the patient with knee osteoarthritis. Ketorolac appears to provide effective medium-term improvement of pain and clinical scores. Further follow-up is recommended to investigate if this trend in sustained.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 127 - 127
1 Mar 2008
Shore B Bourne R MacDonald S McCalden R Busch C Rorabeck C Bhandari R Ganapathy S
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Purpose: Post-operative analgesia using opioids or epidural analgesia can be associated with troublesome side effects. Effective peri-operative analgesia facilitates rehabilitation, improves patient satisfaction and may reduce hospital stay. Locally administered analgesia is effective, avoids systemic drug related side-effects and may be of benefit in minimally invasive joint replacement. This study compares the effects of a peri-articular injection cocktail in patients undergoing total knee and hip replacement surgery

Methods: 128 patients undergoing total knee (TKR) and hip (THR) replacement were randomised to receive a peri-articular intra-operative injection containing ropivacaine, ketorolac, epimorphine and epinephrine or nothing. The anaesthetic analgesic regime was standardised. All patients received patient controlled analgesia (PCA) for 24 hours post surgery, followed by standard analgesia. VAS pain scores during activity and at rest and patient satisfaction scores were recorded pre and post operatively and at 6 week follow up. PCA consumption and overall analgesic requirement were measured.

Results: Both TKR and THR patients used significantly less PCA 6 hours after surgery (p = 0.02 THR, p< 0.01 TKR). TKR patients receiving the injection used significantly less PCA use over 24 hours post surgery (p = 0.013). VAS for pain at 4 hrs post operation was significantly lower in the both groups (p = 0.003 TKR)(p = 0.017 THR). VAS for pain during activity at 24 hours was significantly less (p = 0.001) in the injected TKR group. Overall hospital stay and wound complications were not different between the groups.

Conclusions: Peri-articular analgesia significantly reduces post-operative analgesia requirement in TKR and THR patients. Greater satisfaction and pain relief was seen in TKR patients compared with THR.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 81 - 81
1 Sep 2012
Cheng O Thompson C McKee MD COTS COTS
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Purpose

In a previously published multicenter randomized clinical trial it was shown that young patients (16–60 years-old) with displaced mid-shaft clavicle fractures had superior limb specific outcomes when they were treated with primary plate fixation versus non operative treatment at one year follow-up. This study examines the general health status of this cohort of patients at two-years post injury.

Method

We evaluated the general health of a cohort of patients with displaced mid-shaft clavicle fractures comparing non-operative versus plate fixation at two-years after injury. At the conclusion of our study, eighty-nine patients (fifty-four from the operative group and thirty-five from the non-operative group) completed the two-year follow-up. Outcome analysis included the standard clinical follow-up and SF-36 scores.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 85 - 85
1 Mar 2009
Giron F Aglietti P Cuomo P Losco M Mondanelli N
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Introduction : The purpose of the study is to compare in a randomised clinical double blind trial two methods of hamstring ACL reconstruction, the SIngle Bundle (SB) and the Double Bundle (DB).

Materials and methods: Seventy patients, with a chronic ACL insufficiency, were randomized to receive a unilateral single or double bundle ACL reconstruction. All the operations were performed by the same surgeon using the same two incision outside-in technique. The tibial guide wire was introduced with a 65 degrees Howell guide in extension to avoid impingment. To introduce the second tibial wire (posterolateral wire) a prototype guide that lets you place the wire with a fixed angulation and a fixed distance (9 mm) from the first was used. On the femoral side we used a modified Rear Entry guide. In a SB reconstruction the 10.00 o’clock position (right knee), intermediate between the two anatomic bundles, was used. In a DB reconstruction the first wire was placed in the anteromedial insertion area, close to the “over the top” position on the lateral wall and for the second wire the same prototype guide that gives you the correct angulation and distance with the first (10 mm) was used. The direction was chosen in order to exit 5 mm close to the posterior cartilage. The graft was prepared and pretensioned as to have two arms of the same diameter. It was fixed on the cortex of the tibia by means of a titanium ring bridge when doing a SB and looped around a cortical bony bridge when doing a DB. Tensioning and femoral fixation of the SB was done at 20 degrees, while in the DB tensioning and fixation of the PL bundle was achieved first after cycling at 10–15 degrees and of the AM bundle at 40–45 degrees. Femoral fixation was obtained via RCI titanium interference screws and one additional cortical titanium staple. The same moderately aggressive rehabilitation was utilized in both groups. Outcome assessment was performed by an indipendent observer, blinded to the involved leg and type of reconstruction, using the new IKDC form, the KOOS score, the KT-1000 arthrometer.

Results: All patients reached a minimum follow-up of one year. No difference was found in terms of overall KOOS and IKDC subjective scores. A significant difference was found (p< .001) in KT data and in IKDC final ojective scores (Excellent-A-result: 73% SB and 95% DB). he DB group showed a tred to less pivot shift (glide).

Conclusion: In the short period the DB reconstruction offered better knee stability and better objective results than the 10.00 o’clock SB. Longer follow up and accurate instrumented in vivo rotational stability assessment is probably needed to further disclose small but important differences.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 13 - 13
1 Jan 2014
Maripuri S Gallacher P Bridgens J Kuiper J Kiely N
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Statement of purpose:

A randomised clinical trial was undertaken to find out if treatment time and failure rate in children treated by the Ponseti method differed between below-knee vs above-knee cast groups.

Methods and Results:

Eligible children with idiopathic clubfoot, treated using the Ponseti method, were randomised to either below knee or above knee plaster of Paris casting. Outcome measures were total treatment time and the occurrence of failure, defined as two slippages or a treatment time above eight weeks. Twenty-six children (33 feet) were entered into the trial, with a mean age of 17 days (range 1–40) in the above knee and 11 days (range 5–20) in the below knee group. Because of six failures in the below knee group (38%), the trial was stopped early for ethical reasons. Failure rate was significantly higher in the below-knee group (P 0.039). The median treatment times of six weeks in the below knee and four weeks in the above knee group differed significantly (P 0.01).


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 545 - 545
1 Nov 2011
Jayasuriya R Buckley S Hamer A Kerry R Stockley I Tomouk M Wilkinson J
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In this 2-year randomised clinical trial we examined whether cemented femoral prosthesis geometry affects the pattern of strain-adaptive bone remodelling in the proximal femur after THA. 128 patients undergoing primary THA were randomised to receive a Charnley (shape-closed, no taper), Exeter (force-closed, double-tapered) or C-stem (forced-closed, triple-tapered) prosthesis. All received a cemented Charnley cup. Proximal femoral BMD change over 2 years was measured by DXA. Urine and serum samples were collected at pre-operative baseline and over 1 year post-operatively. N-telopeptides of type-I-collagen (NTX) was measured in urine as a marker of osteoclast activity and Osteocalcin (OC) in serum as a maker of osteoblast activity. Clinical outcome using the Harris and Oxford hip scores, and prosthesis migration measured using digitised radiographs (EBRA-Digital) were measured over 2 years. The baseline characteristics of the subjects in each group were similar (P> 0.05). Decreases in femoral BMD were observed over the first year for all prosthesis designs. Bone loss was greatest (14%) in the proximal medial femur (region 7). The pattern and amount of bone loss observed was similar between all prosthesis designs (P> 0.05). Transient rises in both osteoclast (NTX) and osteoblast (OC) activity also occurred over year 1, and were similar in pattern in the 3 prosthesis groups (p> 0.05). All prostheses showed migration patterns that were true to their design type and similar improvements in clinical hip scores were observed over the 2 year study. Differences in the proposed mechanism of load transfer between prosthesis and host bone in force-closed versus shape-closed femoral prosthesis designs in THA are not major determinants of prosthesis-related remodelling.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 116 - 117
1 May 2011
Bruce-Brand R Moyna N O’Byrne J
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Background: Knee osteoarthritis is responsible for more chronic disability than any other medical condition. Quadriceps femoris muscle weakness has long been associated with disuse atrophy in symptomatic knee osteoarthritis but more recently implicated in the aetiology of this condition. The purpose of this study was to assess the benefits of two interventions aimed at increasing quadriceps strength in subjects with moderate to severe knee osteoarthritis.

Methods: Twenty-eight patients, aged 55–75 years, diagnosed with moderate to severe knee osteoarthritis were recruited and randomised to either a six-week home resistance-training exercise program or a six-week home neuromuscular electrical stimulation (NMES) program. An additional eleven patients matched for age, gender and osteoarthritis severity formed a control group, receiving standard care. The resistance-training group performed six exercises three times per week, while the NMES group used the garment stimulator at the maximum intensity tolerated for twenty minutes five times per week. Outcome measures included isometric and isokinetic quadriceps strength, functional capacity (25m walk test, chair rise test, stair climb test), Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Short Form 36 (SF-36) health surveys. These measures were assessed at baseline, pre-intervention (after familiarisation), post-intervention and at 6-weeks post-intervention. Additionally, quadriceps cross-sectional area (via MRI) and muscle atrophy/hypertrophy gene expression (via vastus lateralis biopsy) were assessed pre- and post-intervention.

Results: Both intervention groups showed significant improvements in all functional tests (e.g. in the stair test, a 22% improvement in the exercise group versus 17% for the NMES group), in the SF36 health survey (25% & 22% respectively), and in quadriceps cross-sectional area (4.3% & 5.4%) immediately post-intervention. An increase in isokinetic strength was seen in the exercise group only (11%). WOMAC score improved only for the NMES group (19%). With the exception of isokinetic strength, all benefits were maintained six weeks post-intervention.

Conclusions: Both a six-week home resistance-training program and a six-week home NMES program produced significant improvements in functional performance as well as physical and mental health for patients with moderate to severe knee osteoarthritis. Home-based NMES is an acceptable alternative to physical therapy for patients with knee osteoarthritis, and is especially appropriate for patients who have difficulty complying with an exercise program.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 254 - 254
1 Nov 2002
Howie D Steele-Scott C Costi K McGee M
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There is a lack of properly undertaken comparative studies of total hip replacement (THR). A randomised trial was established to examine the hypothesis that there are no important differences in clinical outcome at 2 years and at long-term follow-up between cemented and uncemented primary THR in middle aged patients.Eighty-three patients with 90 osteoarthritic hips were randomised to a cemented Exeter THR involving a matte or polished tapered stem (n=47, median age 68yrs) or an uncemented PCA proximally porous-coated cobalt-chrome stem and porous coated press fit cup (n=43, median age 66yrs). Patients underwent immediate full weight bearing post-operatively. The follow-up period is 8 to 16 years. The median Harris hip scores for the cemented and uncemented groups respectively were 92 and 95 at 2 years and 89 and 96 at long-term follow-up. Four cemented hips have been revised for aseptic loosening. There have been no failures of the polished stems. An analysis of a larger series of matt versus polished cemented stems also found that the results of the polished stems were superior. Four uncemented hips have been revised, two more recently for acetabular wear and osteolysis. There was a high rate of radiographic demarcation of the cemented cups. There were no important differences in the clinical scores between cemented and uncemented THR. Some matte surfaced femoral stems failed and this trend was confirmed by analysis of a larger series. Osteolysis around the uncemented acetabular components is a concern. Importantly immediate weight bearing was associated with good results of uncemented stems.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 106 - 106
1 Sep 2012
Masri BA Garbuz DS Duncan CP VGreidanus N Bohm E Valle CJD Gross AE
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Purpose

Dislocation after revision total hip is a common complication. The purpose of this study was to assess whether a large femoral head (36/40mm) would result in a decreased dislocation rate compared to a standard head (32mm).

Method

A randomized clinical trial was undertaken to assess the effect of large femoral heads on dislocation after revision total hip. Patients undergoing revision hip arthroplasty at seven centers were randomized to 32mm head or 36/40mm head. Patients were stratified according to surgeon. Primary endpoint was dislocation. Rates were compared with Fishers exact test. Secondary outcome measures were quality of life: WOMAC, SF-36 and satisfaction. One hundred eighty four patients were randomized: 92 in the 32mm head group and 92 in the large head group. Baseline demographics were similar in the two groups. Patients were followed from two to five years postoperatively


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 105 - 106
1 Mar 2008
Hall J
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Several recent studies have shown an increased incidence of symptomatic non-unions and malunions after non-operative treatment of displaced clavicle fractures. Our multicenter randomized control trial comparing sling treatment and plate fixation shows statistically significant improvement in patient oriented outcome measures at all time points measured over one year of follow-up. Non-operative group complications included six non-unions, one symptomatic malunion and one patient with reflex sympathetic dystrophy in thirty-four patients. Complications in the operative group included one wound dehiscence and two patients requiring plate removal in thirty-seven patients. This study supports plate fixation of acute clavicle fractures in selected cases.

To compare patient oriented outcomes of non-operative and operative treatment of displaced clavicle shaft fractures.

Operative fixation of displaced clavicle shaft fractures provides statistically significant improvement in functional outcome over sling treatment at one year of follow-up.

This study supports operative fixation of displaced clavicle shaft fractures in selected cases.

Seventy-one of one hundred and twenty patients have at least one year of follow-up. Non-operative group (N=34) consisted of twenty-four males with an average age thirty-two injuring fourteen dominant clavicles. The operative group (N= 37) consisted of thirty-three males with an average age of 34.5 years injuring twenty-one dominant clavicles. CSS and DASH scores were statistically different at all time points measured (p=0.001, p=0.021 respectively). Complications in the non-operative group included one patient with RSD, one symptomatic malunion and six patients with non-unions requiring ORIF. In the operative group, two patients experienced local plate irritation and one late wound dehiscence.

Randomization was by sealed envelope. Non-operative treatment was symptomatic in a sling, while operative patients underwent ORIF. CSS, DASH and SF-36 scores were collected at six weeks, three months, six months and twelve months. Statistical analysis was completed by repeated measures multivariate analysis using SPSS.

Recent studies have shown a higher incidence of symptomatic malunions and non-unions after sling treatment. Currently, sling treatment is standard of care for these fractures. Our study shows statistically signifi-cant improvement in functional outcome with operative treatment with few complications. This study supports operative treatment of displaced clavicle shaft fractures in selected cases.

Funding: OTA, Zimmer Inc

Please contact author for graphs and diagrams.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 565 - 565
1 Nov 2011
Secretan CC Beaupre L Johnston DWC Lavoie G
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Purpose: Despite the excellent results of total knee arthroplasty (TKA), controversy over whether or not to resurface the patella persists. Anterior knee pain, which occurs with variable frequency, continues to be a problem in a subset of the TKA patient population. Some clinicians advocate resurfacing all patellae while others cite the complications attributed to patellar resurfacing as reasons to avoid this aspect of the procedure. Still others favour selective resurfacing based on subjective criteria. To address this clinical controversy, we prospectively randomized patients receiving TKA into two groups, those receiving patellar resurfacing and those left without resurfacing to determine clinical outcomes and revisions at five and 10 years postoperatively. Our primary objective was to compare the revision rate following TKA between the two study groups. Secondarily, we compared pain and function at five and 10 years and knee range of motion (ROM) over the first year.

Method: Patients receiving TKA were prospectively enrolled in the study and randomized intraoperatively to either receive patellar resurfacing or have no patellar intervention. All surgeries were performed through the standard medial parapatellar approach. The Smith and Nephew Profix TKA system was implanted in all cases and all subjects followed a standardized post-operative regimen. Subjects were assessed pre-operatively and at 6 months, 1, 3, 5 and 10 years postoperatively for knee ROM, function, and pain using the WOMAC and SF-36 questionnaires. Re-operations and revisions were also documented.

Results: Thirty-nine patients were enrolled in the study. There was 83% patient retention at five years and 74% at 10 years. Study groups were similar in baseline characteristics. At five years, three (18%) revisions had been performed in the retained patella group and one (5%) in the resurfaced group (p=0.31). There were no further revisions between five and 10 years. ROM was similar between the groups at all evaluations (p> 0.05). SF-36 and WOMAC scores demonstrated that both groups improved their pain and function significantly following surgery (p< 0.04).

Conclusion: The decision whether or not to resurface the patella during TKA remains controversial. This study demonstrated that initial results with either technique are comparable, but it appears that there may be clinically significant differences by five years postoperatively. These trends continued throughout the study and were statistically significant at the 10 year mark. Revision surgery was required in 18% of the retained group compared to 5% in the re-surfaced group.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 321 - 321
1 Sep 2005
MacDonald S Bourne R Rorabeck C Cleland D Chess D McCalden R
Full Access

Introduction and Aims: Polyethylene wear continues to be the most significant issue following total hip arthroplasty (THA), leading to the current increase in use of alternative bearing surfaces. We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving THA.

Method: Forty-one patients were randomised to receive a metal (23) or a polyethylene (18) insert with identical femoral and acetabular components. Patients were evaluated pre-operatively at three, six, 12 months and annually thereafter, including an evaluation of erythrocyte and 24-hour urine cobalt, chromium and titanium metal ion levels, validated outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: No patients were lost to follow-up. One patient died of unrelated causes. At an average 4.4 (range 3.3–5.1) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At the latest follow-up erythrocyte cobalt levels were seven times elevated (median 1.2μg/l (metal) Vs 0.18μg/l (poly), p< .001). Urine cobalt levels were 41 times elevated (median 11.9μg/day (metal) Vs 0.29μg/day (poly), p< .001) and urine chromium levels were 14 times elevated (median 4.9μg/day (metal) Vs 0.36μg/day (poly), p< .001). Erthrocyte chromium, titanium and urine titanium were not significantly different between groups. As well, contrary to previous reports, there was not a significant trend towards decreasing ion levels over time.

Conclusion: In this prospective randomised blinded clinical trail comparing metal to polyethyle bearing surfaces, both cobalt and chromium ion levels were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 80 - 80
1 Sep 2012
Mohtadi N Kirkley (Deceased) A Hollinshead R Chan DS Hannaford H Fredine J Sasyniuk T Paolucci EO
Full Access

Purpose

Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy.

Method

Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05).


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 353 - 353
1 Sep 2005
Orec R Pitto R Schmidt R
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Introduction and Aims: Recently, concerns have emerged regarding the high stiffness of acetabular components inserted with alumina ceramic liners, which might potentially cause early migration and loosening. This study was designed to investigate in-vivo the migration pattern of these constructs

Method: Fifty patients (50 hips) operated on using the same surgical technique and the same prosthesis were randomised in two groups. The study group of hips was treated with an alumina ceramic liner, the control group of hips received a polyethylene liner. An alumina femoral head with a diameter of 28mm was used in all hips. Radiostereometric analysis (RSA) was performed to assess migration using serial follow-up radiographs.

Results: The median pre-operative Harris hip score (HHS) was rated 48.9 points in the alumina group, and 47.7 points in the polyethylene group. At the two-year follow-up, the median HHS of the alumina group was rated 94.1 points, and was rated 93.7 points in the polyethylene group. There were no clinical or radiological signs of aseptic loosening. RSA of the alumina group of cups showed a median axial displacement of 0.026 mm (SD 0.35mm). The median axial displacement of the polyethylene group was 0.047 mm (SD 0.26 mm) (p=0.9). The median tilting of the cup was 0.21 degrees (SD 0.54 degrees) in the alumina group, and 0.35 degrees (SD 0.71 degrees) in the polyethylene group (p=0.12).

Conclusion: At an average of two years post-operatively, the cups inserted with an alumina ceramic liner appeared stable, RSA showed low rates of non-progressive migration. Results did not differ from those observed using the same cup inserted with a polyethylene liner.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 338 - 338
1 May 2009
Tregonning G Fransen M Douglas J MacMahon S Norton R
Full Access

The purpose of this study was to determine the benefit and risk of NSAID-based prophylaxis for ectopic bone formation amongst patients undergoing total hip replacement (or revision) surgery.

A double-blind randomised placebo-controlled clinical trial, stratified by treatment site and surgery (primary or revision), was conducted in 20 orthopaedic surgery centres in Australia and New Zealand. 902 patients, undergoing elective primary or revision total hip replacement surgery, were randomly allocated to 14 days treatment with ibuprofen (1200mg daily) or matching placebo commenced within 24 hours of surgery. Patients were only excluded if there was, in the opinion of the responsible physician, a definite indication or contra-indication for treatment with an NSAID during the 14 day study treatment period. Outcomes were assessed six to 12 months after surgery and included changes in self-reported hip pain and physical function (WOMAC), physical performance measures and radiographic evidence of ectopic bone formation.

There was only a 6% loss to follow-up for self-report measures and a 12% loss to follow-up for radiographs. Six to twelve months after surgery, there were no significant differences between the ibuprofen and placebo groups for improvements in hip pain (mean difference, 95% confidence interval: −0.1, −0.4 to 0.2, p=0.6) or physical function (−0.1, −0.4 to 0.2, p=0.5), despite a much reduced risk of ectopic bone formation (relative risk 0.69, 95% confidence interval 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications during the admission period (2.09, 1.00 to 4.39)

These data, from the largest-ever trial of prophylaxis against ectopic bone formation, do not support the use of routine NSAIDs-based prophylaxis for patients undergoing total hip replacement surgery.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 244 - 244
1 May 2009
Goel DP Chan D Mohtadi N Watson K
Full Access

The current standard of care in Calgary, Alberta for management of a ruptured Achilles tendon is surgical repair, typically performed following admission to hospital. The primary objective of this study was to compare the costs of hospital treatment and complications associated with the surgical repair of Achilles tendon ruptures between two groups of patients: Group One = patients enrolled in the randomised clinical trial (RCT) Multicentre Achilles Tendon Treatment Study (MATTS), Group Two = all other non-study patients.

This observational cohort study analyzed all patients surgically treated for Achilles tendon ruptures at Calgary area hospitals over a three-year period (October 2002–September 2005). Inclusion criteria: age eighteen to seventy years, acute rupture.

A total of two hundred and eighty-two patients met the inclusion criteria; thirty-three patients were included in Group One, two hundred and forty-nine patients in Group Two. In Group One, twenty-seven patients (82%) were treated as outpatients, five patients (15%) were ADOP-24hr, and one patient (3%) was admitted. In Group Two, twenty-seven patients (11%) were treated as outpatients, ninety-five patients (38%) were ADOP-24hr, and one hundred and twenty-seven patients (51%) were admitted. The total costs for patients treated as outpatients and requiring overnight stays in Group One were $18,408 and $7,419, respectively. In Group Two, the total cost for outpatients was $18,071 compared to $379,496 for non-study patients requiring overnight stay. If all overnight patients in each group were treated as outpatients, the total savings would be $235,545. There were no serious complications in Group One. In Group Two, complications included two cases of pulmonary embolus, and one case of compartment syndrome requiring readmission. All complications resolved.

Surgical treatment of Achilles tendon rupture can be performed safely and at less cost on an outpatient basis. Participation in this RCT has allowed us to recommend a change in the standard of care in Calgary.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 273 - 274
1 Jul 2011
MacDonald SJ Engh CA Thompson AE Sritulanondha S Naudie D Engh CA
Full Access

Purpose: Metal-on-metal articulations are an increasingly popular choice as an alternate bearing surface in total hip arthroplasty (THA) and Resurfacing implants. One advantage of a metal-on-metal bearing is the use of larger diameter femoral heads with hip simulator data demonstrating reduced wear. We performed a prospective, multicentre, randomized, blinded clinical trial comparing 28mm to 36mm metal-on-metal bearings assessing multiple validated outcome measures and serum, erythrocyte and urine metal ions.

Method: Ninety-one patients were randomized to receive a metal-on-polyethylene (34), a 28mm metal-on-metal (25) or a 36mm metal-on-metal (32) insert. All patients received the same acetabular and femoral component. Patients were evaluated pre-operatively, at 6, 12 months and annually thereafter, including an evaluation of serum, erythrocyte and urine cobalt, chromium, and titanium, outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: At a minimum two years follow-up there were no differences in WOMAC, SF-12, Harris Hip scores or radiographs. Patients receiving metal liners had significantly (p< 0.001) elevated metal ion measurements compared with the polyethylene control group, however there were no differences between the 28mm and 36mm metal-on-metal bearings (Median serum Co (mg/L): 0.14(poly), 0.77(28mm), 0.73(36mm). Median erythrocyte Co (mg/L): 0.11(poly), 0.42(28mm), 0.42(36mm). Median urine Co(mg/day): 0.44(poly), 4.55(28mm), 5.42(36mm)). (Median serum Cr(mg/L): 0.17(poly), 1.29(28mm), 0.91(36mm). Median erythrocyte Cr(mg/ L): 1.10(poly), 1.10(28mm), 1.20(36mm). Median urine Cr(mg/day): 0.27(poly), 1.92(28mm), 2.02(36mm)).

Conclusion: Both cobalt and chromium ion measurements were significantly elevated in the blood and urine of the patients randomized to receive the metal-on-metal bearings at all time intervals. There were no differences seen between the 28mm and 36mm metal-on-metal bearings, keeping all other variables identical. The larger diameter bearing therefore provides the potential clinical advantages of improved range of motion and stability, while providing a similar metal ion profile. While reduced wear is seen with larger diameter metal-on-metal bearings in-vitro, we could not demonstrate a reduction in blood or urine metal ion levels in-vivo.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 338 - 338
1 May 2009
Pitto R Pandit S Clatworthy M Walker C Munro J
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Proximal tibial bone density (BD) is a key determinant in the migration of implants following total knee arthroplasty (TKA). CT-osteodensitometry offers three-dimensional, volumetric analysis of both cortical and cancellous regions and has been shown to be both accurate and reliable about the hip.

The primary objective of this study is to assess differences in the bone remodelling pattern (tibial segment) of patients operated on using fixed or rotating platform, using CT-osteodensitometry. The hypothesis is that the presence of a rotating platform optimises stress distribution along the proximal tibia, resulting in reduced proximal bone remodelling of tibia. The secondary objective is to correlate the osteodensitometry and clinical data at follow-up.

Following completion of the initial assessment and after obtaining written informed consent, the patients were randomly allocated to either a PFC Sigma fixed bearing or a PFC Sigma rotating platform (mobile bearing) total knee system (DePuy, Leeds, UK). Clinical follow-ups were performed at three months, one year, and two years after the index operation. CT scans were performed immediately post-operatively and at one and two years respectively. 52 knees (47 patients) were randomised for cemented TKR management using rotating or fixed tibia platform and followed up at one and two years.

At the two year follow-up, the knee function and patellar scores were comparable in both groups. There were no radiographic signs of loosening, and no revision surgery was performed. Sequential BD measurement from post-operative baseline to two year follow-up showed minimal differences between the fixed and rotating platform implants. Bone density assessment showed a 20% mean loss of cancellous BD and minimal changes of cortical BD, with little differences between the two groups. Loss of cancellous BD appears progressive.

In conclusion, this study shows that the mode of fixation of the TKR polyethylene liner does not influence bone remodelling of the proximal tibia after surgery. This is the first study performed to assess separately cortical and cancellous BD changes in THR. There are no data in the literature for comparison.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 249 - 249
1 May 2009
Johnston D Al Yamani M Beaupre L Huckell JR
Full Access

We compared self-reported pain and function, complications and revision rates, and radiographic outcomes of hydroxylapatite(HA) or cemented tibial fixation in the first five years following primary total knee arthroplasty. This was a randomised clinical trial of eighty-one patients

Prospective, randomised clinical trial. Patients less than seventy years of age with non-inflammatory knee arthritis. Eighty-one patients were randomised at the time of surgery to receive HA or cemented tibial fixation. Subjects were evaluated preoperatively, six months, one and five years postoperatively by a physical therapist who was blinded to group allocation. X-rays were evaluated by an experienced arthroplasty surgeon who did not perform any of the surgeries. Self-reported pain and function, the primary outcomes, were measured by the Western Ontario McMaster (WOMAC) Osteoarthritis Index and the RAND 36-item Health Services Inventory (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. The Knee Society Radiological Score was used to evaluate plain radiographs at each assessment.

There was slightly more pain in HA group at six months as measured by both the WOMAC and RAND-36, a difference that disappeared by the one-year assessment. There were no differences in function, radiographic findings or complications at any time. Finally, no subjects required revision of the tibial prosthesis during the study.

Overall, no significant differences were seen between groups. The initial difference in self-reported pain disappeared by twelve-months postoperatively. At five-years postoperatively, there is no advantage to HA tibial fixation over cemented tibial fixation.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 42 - 43
1 Jan 2011
Maffulli N Franceschi F Longo U Ruzzini L Rizzello G Denaro V
Full Access

Arthroscopic management has been recommended for some SLAP lesions, but no studies have focused on patients over 50 with rotator cuff tear and Type II SLAP lesion. Our hypothesis was that there was no difference in clinical outcome between repairing of the Type II SLAP lesion and tenotomy of the long head of the biceps tendon after having repaired the rotator cuff tear. This was a randomized controlled clinical trial.

We recruited 63 patients. In 31 patients, we repaired the rotator cuff and the Type II SLAP lesion (Group 1). In the other 32 patients, we repaired the rotator cuff and tenomized the long head of the biceps (Group 2). 7 patients (2 in the group 1 and 5 in the group 2) were lost to final follow up.

At the 5.2 year follow-up, statistically significant differences were seen with respect to the UCLA score and ROM values. In Group 1 (SLAP repair and rotator cuff repair), the UCLA showed a statistically significant improvement from a pre-operative average rating of 10.4 (range 6 to 14) to an average of 27.9 (24–35) postoperatively (P< 0.001). In Group 2 (biceps tenotomy and rotator cuff repair) the UCLA showed a statistically significant improvement from a pre-operative average rating of 10.1 (range 5 to 14) to an average of 32.1 (range 30 to 35) post-operatively (P< 0.001) There was statistically significant difference in total post-operative UCLA scores and ROM when comparing the two groups post-operatively (P< 0.05).

There are no advantages in repairing a Type II SLAP lesion when associated with a rotator cuff tear in patients over 50. Rotator cuff repair alone is sufficient to produce a good post-operative outcome, allowing to avoid post-operative stiffness of the shoulder.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 159 - 159
1 Sep 2012
Beaulé PE Dinh L Gauthier L Kim PR Feibel RJ Thurston PR Giachino AA
Full Access

Purpose

Use of a large femoral head metal-on-metal bearing in total hip arthroplasty may offer an advantage in terms of dislocation rates and more natural joint kinematics. The acetabular component is more rigid however in these prostheses and if not placed accurately can lead to increased levels of metal ion release. A prospective randomized controlled trial was conducted to quantify bone mineral density on the acetabular side, as well as compare metal ion levels from a standard metal-on-polyethylene bearing to a large head metal-on-metal bearing in primary total hip arthroplasty.

Method

Fifty patients were randomized to receive total hip arthroplasty with either the CONSERVE A-Class Total Hip with BFH femoral head or the Lineage acetabular component with polyethylene insert and cobalt chrome femoral head. There were 27 females (11 BFH) and 23 males (14 BFH), with a mean overall age of 61.6 (range 47.7–73.2). Serum levels of cobalt, chromium, and titanium were measured at regular intervals up to two years. Harris Hip Score, WOMAC, UCLA, and RAND-36 were completed at these same intervals. Standard radiographs as well as periprosthetic BMD were performed.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 254 - 254
1 May 2009
Roy L Carrier M Laflamme Y
Full Access

This study is a prospective randomised clinical trial which primary objective was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for hemiarthroplasty in acute femoral neck fractures.

Fifty-five patients have been randomised: twenty-four patients in the mini-incision surgery group (MIS) and thirty-one patients in the standard incision group (STD). The mini-incision was defined as less than 8cm. Data were collected preoperatively and at four days, three and six weeks, three, six, twelve, and twenty-four months postoperatively. The Jaglal Lower Extremity Measurement (LEM) and the Time Up and Go (TUG) where evaluated. Secondary endpoints of pain, function, and quality of life where assessed by the components of the Harris hip Score and SF-36. Radiograghic outcomes where also evaluated.

The demographic data where similar between the two groups for age, gender, weight, type of anaesthesia used, pre-operative haemoglobin and preoperative comorbidities. There was no significant difference for operative time, blood losses, 72h postoperative haemoglobin and the need for transfusion therapy between the two groups. Also, there was no difference between the groups for post-operative morphine use and pain evaluation with the Visual Analog Scale. The functional assessment using the LEM, TUG, Harris Hip score and SF-36 scores did not demonstrate any statistically significant difference between mini and standard incision.

This study demonstrates that the clinical and functional outcomes measured are similar between the two groups, thus limiting the potential benefits of MIS in hip fracture patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 301 - 301
1 May 2010
Hordam B Soballe K Pedersen PU Sabroe S Mejdahl S
Full Access

Objective: To study the effect in health status of telephone contact 2+10 weeks after total hip replacement (THR) during the first nine months after surgery. Not all of patient have improvement in their health status and quality of life, that the surgery benefits them.

Method: A randomised clinical trial enrolled 180 patients aged 65+ focusing on patients’ health status using SF-36, 4 weeks pre–to 3 and 9 months postoperative were carried out. Patients were randomised 4 weeks preoperative either to control or intervention group. Both groups received the conventional treatment. Furthermore the intervention group had postoperative telephone monitoring two and ten weeks after surgery Patients were given counselling by using an interview-guide within eight main themes referring to patients’ actual situation after THR.

Results: All patients experienced increase in their health status after THA. The intervention significantly reduced the time for patients to reach their habitual level as patients in the intervention group reached their habitual level at three months whereas patients in the control group reached this level after nine months.

Conclusion: Support by phone contact after THR seems to benefit patients’ outcome.

The presentation is based on the results of the nursing intervention program by using telephone contact to elderly patients with hip replacement after discharge.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 1 - 1
1 Sep 2012
Ramaskandhan J Malviya A Bowman R Lingard E Holland J
Full Access

Introduction

Cemented stems have shown 90–100% survivorship when coupled with polyethylene acetabular component. This study aims to compare cemented stem behaviour in combination with large metal on metal (MOM) vs. metal on poly (MOP) bearings.

Patients and Methods

100 patients were recruited into a single centre RCT (we required 40 in each group for power .90 to confirm stem subsidence of >0.5mm at 2 years; p< 0.05). Recruits were randomized to MOP (28mm) or MOM femoral heads with CPCS cemented femoral stem. Assessments included X-rays (AP pelvis), Harris Hip Scores, blood metal ion levels and patient questionnaires (WOMAC, SF-36, satisfaction questionnaire). Evaluations were done pre-operatively and 3, 12 and 24 months post operatively; blood metal ion measures at 1 year.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 166 - 166
1 Sep 2012
Mohtadi NG Chan DS Hollinshead R Boorman R Hiemstra L Lo I Hannaford H Fredine J Sasyniuk T Paolucci EO
Full Access

Purpose

This prospective, expertise-based randomized clinical trial compares arthroscopic to open shoulder stabilization by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior shoulder instability, and determining the incidence of recurrent instability at 2-years post-operatively.

Method

One hundred and ninety-six patients were randomly allocated to arthroscopic (n=98) or open (n=98) repair using an expertise-based approach with a surgeon specializing in one type of surgery. Randomization was performed using computer-generation, variable block sizes and concealed envelopes. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years post-operatively. These outcomes included the Western Ontario Shoulder Instability (WOSI) Index quality of life outcome and the American Shoulder and Elbow Society (ASES) functional outcome. Both outcomes were measured on a visual analog scale from 0 to 100, where a higher score represents better quality of life or function. Recurrent instability was categorized as traumatic/atraumatic, and as a subluxation/dislocation. Analyses included ANOVA of repeated measures and independent t-tests. Bonferroni adjustments for pairwise contrasts were made for multiple comparisons. Chi-squared analyses were performed on recurrence. Statistical significance was reported at p < 0.05.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 203 - 203
1 Sep 2012
Soroceanu A Oxner W Alexander D Shakespeare D
Full Access

Purpose

Bone morphogenic protein (BMP-2) is used in spinal arthrodesis to induce bone growth. Studies have demonstrated that it achieves similar fusion rates compared to iliac crest bone graft when used in instrumented fusions. Our study aims at evaluating the requirement for instrumentation in one and two-level spinal arthrodeses when BMP-2 is used in conjunction with local bone to achieve fusion.

Method

50 patients were recruited and randomized to instrumented versus non-instrumented spinal arthrodesis. BMP-2 with local autologous bone was used in all patients. Patients are evaluated at 3-months, 6-months, 12-months, and 24-months postoperatively with questionnaires to assess clinical outcome (ODI, VAS and SF-36), and PA and lateral x-rays of the spine to assess radiographic fusion (Lenke score). At 24 months, a thin-cut (1mm) CT scan was performed.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 239 - 239
1 May 2009
MacDonald S Bourne RB Chess D McCalden RW Rorabeck CH Thompson A
Full Access

We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving a THA.

Forty-one patients were randomised to receive a metal (twenty-three) or a polyethylene (eighteen) insert with identical femoral and acetabular components. The metal bearing was a 28mm low carbon on high carbon couple. Patients were evaluated pre-operatively, at three, six, twelve months and annually thereafter, including an evaluation of erythrocyte and urine cobalt, chromium, and titanium, outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

No patients were lost to follow-up. At an average 7.2 (range 6.1 – 7.8) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At most recent follow-up, compared to the polyethylene control group, patients receiving a metal on metal bearing had erythrocyte cobalt levels were eleven times elevated (median 1.4 μg/L (metal) vs 0.12 μg/L (poly), p< .001). Urine cobalt levels were thirty-nine times elevated (median 11.4 μg/L/day (metal) vs 0.29 μg/day (poly), p< .001) and urine chromium levels were twenty-eight times elevated (median 4.75 μg/day (metal) vs 0.17 μg/day (poly), p< .001). Additionally the metal ion levels reached an early steady state level and did not decrease over time. (Erythrocyte Co (μg/L): 1.29 (6 mos), 1.20 (1 yr), 1.0 (2 yr), 1.10 (3 yr), 1.35 (4 yr), 1.40 (5 yr)).

Both cobalt and chromium ion measurements were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA at all time intervals. Contrary to previous reports, in 34% of patients with a metal liner, metal ion (erythrocyte cobalt) elevation was still increasing at latest follow-up, and in the overall metal on metal patient cohort, metal ion median levels were not decreasing over time. As in polyethylene wear data, metal ion results are not necessarily generalizable, but are bearing design specific.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 584 - 584
1 Oct 2010
Brookes-Fazakerley S Atkinson C Walker C
Full Access

Closure with interrupted mattress sutures is useful where careful skin apposition is required following hindfoot surgery. However, suture removal can be technically difficult and painful. Modification with an additional suture loop creates a “traction loop suture”. We hypothesise this technique makes suture removal quicker and reduced tension placed on sutures during their removal reduces pain.

37 patients undergoing elective hindfoot surgery took part in a prospective clinical trial comparing traditional interrupted sutures with traction loop sutures. Each patient underwent half of each wound sutured with both types. Sutures were removed at 2 weeks and pain levels were determined during removal using the 10 cm visual analogue pain scale. Duration of time taken for each type of suture removal was measured. Wound complications were recorded at 2 and 6 weeks post-operative.

Results demonstrated traction loop sutures were 43% less painful to remove per wound than normal interrupted sutures (mean difference 1.06; standard deviation 1.56; 95% confidence interval 0.50 to 1.62; p-value 0.001). Traction loop sutures were also 31% quicker to remove per wound (mean difference 15.72 seconds; standard deviation 19.98; confidence interval 8.51 to 22.93; p-value < 0.001). At 2 weeks, 1 normally sutured wound suffered dehiscence. At 6 weeks, no complications were noted in either group.

Our results demonstrate that traction loop sutures provide a quick and simple means of reducing patients’ pain and time during suture removal. Traction loop suturing technique could be applied to other surgical specialities where interrupted suture closure is indicated.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.

Cite this article: Bone Joint J 2024;106-B(2):114–120.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 550 - 559
5 Jul 2024
Ronaldson SJ Cook E Mitchell A Fairhurst CM Reed M Martin BC Torgerson DJ

Aims

To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS).

Methods

A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.


Aims

Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus.

Methods

Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 38 - 45
1 Jan 2024
Leal J Mirza B Davies L Fletcher H Stokes J Cook JA Price A Beard DJ

Aims

The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness.

Methods

A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims

To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.

Methods

A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims

To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective.

Methods

We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.


Aims

The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs).

Methods

A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 324 - 335
1 Apr 2024
Fontalis A Kayani B Plastow R Giebaly DE Tahmassebi J Haddad IC Chambers A Mancino F Konan S Haddad FS

Aims

Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA.

Methods

This prospective randomized controlled trial (RCT) included 60 patients with symptomatic hip osteoarthritis undergoing conventional THA (CO THA) versus robotic arm-assisted THA (RO THA). Patients in both arms underwent pre- and postoperative CT scans, and a patient-specific plan was created using the robotic software. The COR, combined offset, acetabular orientation, and leg length discrepancy were measured on the pre- and postoperative CT scanogram at six weeks following surgery.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims

Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures.

Methods

The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Methods

This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 236 - 236
1 Mar 2010
Casserley-Feeney S Bury G Daly L Hurley D
Full Access

Background & Purpose: This pragmatic randomised clinical trial (RCT) investigated differences in the clinical outcomes of physiotherapy for low back pain (LBP) delivered in

public hospital-based secondary care versus

private community-based primary care in Ireland.

Methods: Between March 2005 and May 2006, 160 consenting subjects [110F, 50M; mean age (SD) yrs: 41.28 (12.83)] were recruited, stratified (acute: < 3/12; chronic: > 3/12), and randomly allocated to public hospital (H) or private community (P) physiotherapy. Subjects completed clinical outcomes (Roland Morris Disability Questionnaire (RMDQ). SF-36, Fear Avoidance Beliefs & Back Beliefs Questionnaires) at baseline, 3, 6 and 12 months post randomisation and the Patient Satisfaction with Outpatient Physical Therapy (PTOPS) survey at the end of treatment. Intention-to-treat analysis was conducted using the Statistical Package for the Social Sciences (SPSS, Version 12).

Results: There were no significant differences between groups at baseline (p> 0.05). Patient response rates were 85% (n=137), 80% (n=128) and 74% (n=118) at 3, 6, and 12 months. Despite significantly longer waiting times for public hospital physiotherapy, repeated measures ANOVA found no significant differences over time between groups for any of the outcome measures (p> 0.05), except ‘patient satisfaction with outcome,’ which was significantly higher in the P group (median difference: 0.00; p=0.020, Mann Whitney U=1324.50).

Conclusions & Implications: The trial cannot recommend one physiotherapy setting over the other for LBP management. However, the limited adherence to LBP clinical guidelines in both settings and the lack of improvement in psychosocial outcomes in subjects managed in both settings warrant further investigation.

Acknowledgements: Physiotherapists, General practitioners and patients in both settings.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 195 - 195
1 Mar 2010
Harato K Bourne R Hart J Victor J Snyder M Ries M
Full Access

The purpose of the current study was to compare mid-term outcomes of posterior cruciate retaining(CR) versus posterior cruciate substituting (PS)procedures, using the Genesis II total knee arthroplasty (TKA) system(Smith and Nephew, Memphis TN). Ninety nine CR and 93 PS TKA’s were analysed in this prospective, randomised, clinical trial. Surgeries were performed at seven medical centres by participating surgeons. Clinical outcomes (Knee Society Score, Range of Motion, WOMAC, SF 12 : and radiographic findings), in addition to postoperative complications, were evaluated with a minimum follow-up of five years. Following data analysis, there were no Significant differences in patient demographics or pre-operative clinical measures between the two groups. At the latest follow-up interval, no Significant differences were found between the CR and PS groups with regard to functional assessment, patient satisfaction or post-operative complications. However the PS group did display statistically Significant improvements in range of motion when compared with the CR group. The results of this investigation would suggest that while comparable in regards to supporting good clinical outcomes, the PS Genesis II design does appear to support significantly improved post-operative range of motion when compared with the CR design


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 189 - 192
1 Feb 2022
Scott CEH Clement ND Davis ET Haddad FS


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1561 - 1570
1 Oct 2021
Blyth MJG Banger MS Doonan J Jones BG MacLean AD Rowe PJ

Aims

The aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively.

Methods

A per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status.


Aims

To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component.

Methods

Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.


Aims

This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.

Methods

The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

Aims

A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

Methods

A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.


The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 98 - 104
1 Jan 2021
van Ooij B Sierevelt IN van der Vis HM Hoornenborg D Haverkamp D

Aims

For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA.

Methods

A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization.


Bone & Joint Research
Vol. 9, Issue 10 | Pages 653 - 666
7 Oct 2020
Li W Li G Chen W Cong L

Aims

The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease.

Methods

A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed.


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 56 - 63
1 Jan 2018
Smith NA Parsons N Wright D Hutchinson C Metcalfe A Thompson P Costa ML Spalding T

Aims

Meniscal allograft transplantation is undertaken to improve pain and function in patients with a symptomatic meniscal deficient knee compartment. While case series have shown improvements in patient reported outcome measures (PROMs), its efficacy has not been rigorously evaluated. This study aimed to compare PROMs in patients having meniscal transplantation with those having personalized physiotherapy at 12 months.

Patients and Methods

A single-centre assessor-blinded, comprehensive cohort study, incorporating a pilot randomized controlled trial (RCT) was performed on patients with a symptomatic compartment of the knee in which a (sub)total meniscectomy had previously been performed. They were randomized to be treated either with a meniscal allograft transplantation or personalized physiotherapy, and stratified for malalignment of the limb. They entered the preference groups if they were not willing to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score and Lysholm score and complications were collected at baseline and at four, eight and 12 months following the interventions.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 33 - 41
1 Jan 2020
Norman JG Brealey S Keding A Torgerson D Rangan A

Aims

The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures

Methods

A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1550 - 1556
1 Dec 2019
Mc Colgan R Dalton DM Cassar-Gheiti AJ Fox CM O’Sullivan ME

Aims

The aim of this study was to examine trends in the management of fractures of the distal radius in Ireland over a ten-year period, and to determine if there were any changes in response to the English Distal Radius Acute Fracture Fixation Trial (DRAFFT).

Patients and Methods

Data was grouped into annual intervals from 2008 to 2017. All adult inpatient episodes that involved emergency surgery for fractures of the distal radius were included


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1472 - 1475
1 Dec 2019
Keene DJ Willett K

The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction.

Cite this article: Bone Joint J 2019;101-B:1472–1475.


Aims

The aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury.

Patients and Methods

We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture.


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1148 - 1156
1 Sep 2018
Ferguson RJ Broomfield JA Malak TT Palmer AJR Whitwell D Kendrick B Taylor A Glyn-Jones S

Aims

The aim of this study was to determine the stability of a new short femoral stem compared with a conventional femoral stem in patients undergoing cementless total hip arthroplasty (THA), in a prospective randomized controlled trial using radiostereometric analysis (RSA).

Patients and Methods

A total of 53 patients were randomized to receive cementless THA with either a short femoral stem (MiniHip, 26 patients, mean age: 52 years, nine male) or a conventional length femoral stem (MetaFix, 23 patients, mean age: 53 years, 11 male). All patients received the same cementless acetabular component. Two-year follow-up was available on 38 patients. Stability was assessed through migration and dynamically inducible micromotion. Radiographs for RSA were taken postoperatively and at three, six, 12, 18, and 24 months.


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1025 - 1032
1 Aug 2018
Wang D Wang H Luo Z Meng W Pei F Li Q Zhou Z Zeng W

Aims

The aim of this study was to identify the most effective regimen of multiple doses of oral tranexamic acid (TXA) in achieving maximum reduction of blood loss in total knee arthroplasty (TKA).

Patients and Methods

In this randomized controlled trial, 200 patients were randomized to receive a single dose of 2.0 g of TXA orally two hours preoperatively (group A), a single dose of TXA followed by 1.0 g orally three hours postoperatively (group B), a single dose of TXA followed by 1.0 g three and nine hours postoperatively (group C), or a single dose of TXA followed by 1.0 g orally three, nine, and 15 hours postoperatively (group D). All patients followed a routine enhanced-recovery protocol. The primary outcome measure was the total blood loss. Secondary outcome measures were hidden blood loss (HBL), reduction in the level of haemoglobin, the rate of transfusion and adverse events.


The Bone & Joint Journal
Vol. 100-B, Issue 5 | Pages 624 - 633
1 May 2018
Maredza M Petrou S Dritsaki M Achten J Griffin J Lamb SE Parsons NR Costa ML

Aim

The aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and ‘locking’ plate fixation in the treatment of extra-articular fractures of the distal tibia.

Patients and Methods

An economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates.


Aims

This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures.

Patients and Methods

This was a pragmatic, multicentre, multisurgeon, two-arm, parallel group, randomized standard-of-care controlled trial. It was embedded within the WHiTE Comprehensive Cohort Study. The sample size was 964 patients. The setting was five National Health Service Trauma Hospitals in England. A total of 964 patients over 60 years of age who required hemiarthroplasty of the hip between February 2015 and March 2016 were included. A standardized measure of health outcome, the EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and at four months following the operation.


Bone & Joint Open
Vol. 4, Issue 9 | Pages 713 - 719
19 Sep 2023
Gregersen MG Justad-Berg RT Gill NEQ Saatvedt O Aas LK Molund M

Aims. Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion. Randomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences. Cite this article: Bone Jt Open 2023;4(9):713–719


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 33 - 33
7 Aug 2024
Williams R Evans S Maitre CL Jones A
Full Access

Background. It has become increasingly important to conduct studies assessing clinical outcomes, reoperation rates, and revision rates to better define the indications and efficacy of lumbar spinal procedures and its association with symptomatic adjacent segment degeneration (sASD). Adjacent segment degeneration (ASD) is defined as the radiographic change in the intervertebral discs adjacent to the surgically treated spinal level. SASD represents adjacent segment degeneration which causes pain or numbness due to post-operative spinal instability or nerve compression at the same level. The most common reason for early reoperation and late operation is sASD, therefore is in our best interest to understand the causes of ASD and make steps to limit the occurrence. Method. A comprehensive literature search was performed selecting Randomized controlled trials (RCTs) and retrospective or prospective studies published up to December 2023. Meta-analysis was performed on 38 studies that met the inclusion criteria and included data of clinical outcomes of patients who had degenerative disc disease, disc herniation, radiculopathy, and spondylolisthesis and underwent lumbar fusion or motion-preservation device surgery; and reported on the prevalence of ASD, sASD, reoperation rate, visual analogue score (VAS), and Oswestry disability index (ODI) improvement. Results. When compared to fusion surgery, a significant reduction of ASD, sASD and reoperation was observed in the cohort of patients that underwent motion-preserving surgery. Conclusion. Dynamic fusion constructs are treatment options that may help to prevent sASD. Conflicts of interest. This research was funded by Paradigm Spine. Sources of funding. Paradigm Spine


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 532 - 539
1 Jun 2024
Lei T Wang Y Li M Hua L

Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023. Randomized controlled trials (RCTs) which evaluate the efficacy of HA, PRP, local anaesthetic, steroid, steroid+anaesthetic, HA+PRP, and physiological saline injection as a placebo, for patients with hip OA were included. Results. In this meta-analysis of 16 RCTs with a total of 1,735 participants, steroid injection was found to be significantly more effective than placebo injection on reported pain at three months, but no significant difference was observed at six months. Furthermore, steroid injection was considerably more effective than placebo injection for functional outcomes at three months, while the combination of HA+PRP injection was substantially more effective at six months. Conclusion. Evidence suggests that steroid injection is more effective than saline injection for the treatment of hip joint pain, and restoration of functional outcomes. Cite this article: Bone Joint J 2024;106-B(6):532–539


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 64 - 64
4 Apr 2023
Hartland A Islam R Teoh K Rashid M
Full Access

There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included pain (visual analogue scale VAS), rate of Popeye deformity, and operative time. 860 patients from 11 RCTs (426 tenotomy vs 434 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.14, 95% CI −0.04 to 0.32; p=0.13). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. There was no significant difference for pain (VAS). Tenodesis resulted in a lower rate of Popeye deformity (OR 0.29, 95% CI 0.19 to 0.45, p < 0.00001). Tenotomy demonstrated a shorter operative time (MD 15.21, 95% CI 1.06 to 29.36, p < 0.00001). Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. A large multi-centre clinical effectiveness randomised controlled trial is needed to provide clarity in this area


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 47 - 47
17 Apr 2023
Akhtar R
Full Access

To compare the efficacy of intra-articular and intravenous modes of administration of tranexamic acid in primary total knee arthroplasty in terms of blood loss and fall in haemoglobin level. Study Design: Randomized controlled trial. Duration of Study: Six months, from May 2019 to Nov 2019. Seventy-eight patients were included in the study. All patients undergoing unilateral primary total knee replacement were included in the study. Exclusion criteria were patients with hepatitis B and C, history of previous knee replacement, bilateral total knee replacement, allergy to TXA, Hb less than 11g/dl in males and less than 10g/dl in females, renal dysfunction, use of anticoagulants for 7 days prior to surgery and history of thromboembolic diseases. Patients were randomly divided into group A and B. Group A patients undergoing unilateral primary total knee replacement (TKR) were given intravenous tranexamic acid (TXA) while group B were infiltrated with intra-articular TXA. Volume of drain output, fall in haemoglobin (Hb) level and need for blood transfusion were measured immediately after surgery and at 12 and 24 hours post operatively in both groups. The study included 35 (44.87%) male and 43 (55.13%) female patients. Mean age of patients was 61 ± 6.59 years. The mean drain output calculated immediately after surgery in group A was 45.38 ± 20.75 ml compared with 47.95 ± 23.86 ml in group B (p=0.73). At 24 hours post operatively, mean drain output was 263.21 ± 38.50 ml in intravenous group versus 243.59 ± 70.73 ml in intra-articular group (p=0.46). Regarding fall in Hb level, both groups showed no significant difference (p>0.05). About 12.82% (n=5) patients in group A compared to 10.26% (n=4) patients required blood transfusion post operatively (p=0.72). Intra-articular and intravenous TXA are equally effective in patients undergoing primary total knee arthroplasty in reducing post-operative blood loss


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 51 - 51
1 Dec 2022
Gazendam A Bali K Tushinski D Petruccelli D Winemaker MJ de Beer J Wood T
Full Access

During total knee arthroplasty (TKA), a tourniquet is often used intraoperatively. There are proposed benefits of tourniquet use including shorter duration of surgery, improved surgical field visualization and increased cement penetration which may improve implant longevity. However, there are also cited side effects that include increased post-operative pain, slowed recovery, skin bruising, neurovascular injury and quadriceps weakness. Randomized controlled trials have demonstrated no differences in implant longevity, however they are limited by short follow-up and small sample sizes. The objective of the current study was to evaluate the rates of revision surgery among patients undergoing cemented TKA with or without an intraoperative tourniquet and to understand the causes and risk factors for failure. A retrospective cohort study was undertaken of all patients who received a primary, cemented TKA at a high-volume arthroplasty centre from January 1999 to December 2010. Patients who underwent surgery without the use of a tourniquet and those who had a tourniquet inflated for the entirety of the case were included. The causes and timing of revision surgery were recorded and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to reduce the loss to follow-up. Survivorship analysis was performed with the use of Kaplan-Meier curves to determine overall survival rates at final follow-up. A Cox proportional hazards model was utilized to evaluate independent predictors of revision surgery. Data from 3939 cases of primary cemented TKA were available for analysis. There were 2276 (58%) cases in which a tourniquet was used for the duration of the surgery and 1663 (42%) cases in which a tourniquet was not utilized. Mean time from the primary TKA was 14.7 years (range 0 days - 22.8 years) when censored by death or revision surgery. There were 150 recorded revisions in the entire cohort, with periprosthetic joint infection (n=50) and aseptic loosening (n=41) being the most common causes for revision. The cumulative survival at final follow-up for the tourniquetless group was 93.8% at final follow-up while the cumulative survival at final follow-up for the tourniquet group was 96.9% at final follow-up. Tourniquetless surgery was an independent predictor for all-cause revision with an HR of 1.53 (95% CI 1.1, 2.1, p=0.011). Younger age and male sex were also independent factors for all cause revision. The results of the current study demonstrate higher all-cause revision rates with tourniquetless surgery in a large cohort of patients undergoing primary cemented TKA. The available literature consists of short-term trials and registry data, which have inherent limitations. Potential causes for increased revision rates in the tourniquetless group include reduced cement penetration, increased intraoperative blood loss and longer surgical. The results of the current study should be taken into consideration, alongside the known risks and benefits of tourniquet use, when considering intraoperative tourniquet use in cemented TKA


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 35 - 35
1 Nov 2021
Hartland A Islam R Teoh K Rashid M
Full Access

Introduction and Objective. There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. Materials and Methods. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included visual analogue scale (VAS), rate of cosmetic deformity (Popeye sign), range of motion, operative time, and elbow flexion strength. Results. 751 patients from 10 RCTs demonstrated (369 tenotomy vs 382 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.17 95% CI −0.02 to 0.36, p=0.09). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. Secondary outcomes including VAS, shoulder external rotation, and elbow flexion strength did not reveal any significant difference. Tenodesis resulted in a lower rate of Popeye deformity (OR 0.27 95% CI 0.16 to 0.45, p<0.00001). Conclusions. Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. This finding was irrespective of the whether the rotator cuff was intact


The Bone & Joint Journal
Vol. 102-B, Issue 4 | Pages 407 - 413
1 Apr 2020
Vermue H Lambrechts J Tampere T Arnout N Auvinet E Victor J

The application of robotics in the operating theatre for knee arthroplasty remains controversial. As with all new technology, the introduction of new systems might be associated with a learning curve. However, guidelines on how to assess the introduction of robotics in the operating theatre are lacking. This systematic review aims to evaluate the current evidence on the learning curve of robot-assisted knee arthroplasty. An extensive literature search of PubMed, Medline, Embase, Web of Science, and Cochrane Library was conducted. Randomized controlled trials, comparative studies, and cohort studies were included. Outcomes assessed included: time required for surgery, stress levels of the surgical team, complications in regard to surgical experience level or time needed for surgery, size prediction of preoperative templating, and alignment according to the number of knee arthroplasties performed. A total of 11 studies met the inclusion criteria. Most were of medium to low quality. The operating time of robot-assisted total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA) is associated with a learning curve of between six to 20 cases and six to 36 cases respectively. Surgical team stress levels show a learning curve of seven cases in TKA and six cases for UKA. Experience with the robotic systems did not influence implant positioning, preoperative planning, and postoperative complications. Robot-assisted TKA and UKA is associated with a learning curve regarding operating time and surgical team stress levels. Future evaluation of robotics in the operating theatre should include detailed measurement of the various aspects of the total operating time, including total robotic time and time needed for preoperative planning. The prior experience of the surgical team should also be evaluated and reported. Cite this article: Bone Joint J 2020;102-B(4):407–413


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 32 - 32
1 Sep 2019
Lemmers G van Lankveld W van der Wees P Westert G Staal J
Full Access

Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS. Randomized controlled trials (RCTs) and observational studies (OSs), comparing imaging versus no imaging on targeted outcomes were extracted from medical databases until October 2017. Data extraction and risk of bias assessment was performed independently by two reviewers. The quality of the body of evidence was determined using GRADE methodology. Results. Moderate quality evidence (1 RCT; n=421) supports that direct costs increase for patients undergoing radiography. Low quality evidence (3 OSs; n=9535) supports that early MRI leads to a large increase in costs. Moderate quality evidence (2 RCTs, 6 OSs; n=19392) supports that performing MRI, radiography or CT is associated with increased healthcare utilization. Two RCTs (n=667) showed no significant differences between radiography or MRI groups compared with no imaging groups on absence from work. However, the results of two observational studies (n=7765) did show significantly greater absence from work in the imaging groups compared to the no imaging-groups. Conclusions. Imaging in LBP is associated with higher medical costs and increased healthcare utilisation. There are indications that it also leads to higher absence from work. No conflicts of interest. No funding obtained


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 4 - 4
1 Feb 2018
Abbey H Nanke L
Full Access

Background. Chronic pain is a complex condition that demonstrates better outcomes in multidisciplinary rehabilitation, typically delivered to groups of patients by tertiary healthcare teams. An inter-disciplinary pain management course for individual patients was developed to increase the scope of physical therapists working in primary care by integrating osteopathic manual therapy with psychological interventions from Acceptance and Commitment Therapy (ACT), a form of ‘3rd wave’ Cognitive Behaviour Therapy. Method and Results. A single cohort study with pre-course (n=180) and post-course (n=79) self-report measures (44% response rate) evaluated six week interventions which combined individual manual therapy with self-management, delivered by teams of qualified and student osteopaths. Data included: quality of life (European Quality of Life Questionnaire); pain, mood and coping (Bournemouth Questionnaire); psychological flexibility (Revised Acceptance and Action Questionnaire); and mindfulness (Freiburg Mindfulness Inventory). Participants were predominantly female (68%), unemployed (59%), with an average age of 49 and pain duration of more than 12 months (86%). Commonly reported symptoms were low back pain (82%), neck pain (60%) and multiple sites (86%). At six months, there were statistically significant improvements in all four outcome measures (p<0.0005), with promising effect sizes in quality of life and pain coping (r=0.52) which appeared to be mediated by changes in psychological flexibility. Conclusions. This innovative, integrated, patient-centred chronic pain management course demonstrated promising outcomes when delivered by osteopaths with varying experience. Randomised clinical trials are now needed to assess outcomes in comparison with standard care, and optimal ways of training physical therapists to deliver effective psychological interventions. Conflicts of interest: No conflicts of interest. Sources of funding: A Department of Health ‘Innovation, Excellence and Strategic Development’ (IESD) grant for the Voluntary Sector Investment Programme (AIMS Ref: 2527190; ISRCTN: 04892266). The results of this study are being submitted for publication in the International Journal of Osteopathic Medicine and will be presented at the COME Collaboration Osteopathic Conference in Barcelona on September 30th 2017 and at the Therapy Expo 2017 at the NEC in Birmingham on November 22nd 2017


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 11 - 11
1 Nov 2016
Iannotti J
Full Access

CT-based three-dimensional (3D) pre-operative imaging along with 2D orthogonal sections defined by the plane of the scapula (axial, sagittal and coronal planes) has been demonstrated by many research groups to be a very accurate way to define the bone pathology and alignment/subluxation of the humeral head in relationship to the center line of the scapula or the center of the glenoid fossa. When 3D CT imaging is combined with 3D implant templating the surgeon is best able to define the optimal implant and its location for the desired correction of the bone abnormalities. The use and value of 3D imaging is best when the there is more severe bone pathology and deformity. Transferring the computer-based information of implant location to the surgical site can involve multiple methods. The three methods discussed in the literature to date including use of standard instrumentation in a manner specified by the pre-operative planning, use of single-use patient specific instrumentation and use of reusable patient specific instrumentation. Several cadaver and sawbone studies have demonstrated significant improvement in placement of the glenoid implant with both single use and reusable patient specific instrumentation when compared to use of 2D imaging and standard instrumentation. Randomised clinical trials have also shown that 3D planning and implant templating is very effective in accurate placement of the implant in the desired location using all three types of instrumentation. The optimal use of this technology is dependent upon the severity of the pathology and the experience and preference of the surgeon. With more severe pathology and less surgeon experience 3D pre-operative imaging and templating and use of some level of patient specific instrumentation provides more accurate placement of the glenoid implant


Bone & Joint Open
Vol. 4, Issue 3 | Pages 146 - 157
7 Mar 2023
Camilleri-Brennan J James S McDaid C Adamson J Jones K O'Carroll G Akhter Z Eltayeb M Sharma H

Aims

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

Methods

A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 121 - 127
1 Feb 2024
Filtes P Sobol K Lin C Anil U Roberts T Pargas-Colina C Castañeda P

Aims

Perthes' disease (PD) is a relatively rare syndrome of idiopathic osteonecrosis of the proximal femoral epiphysis. Treatment for Perthes' disease is controversial due to the many options available, with no clear superiority of one treatment over another. Despite having few evidence-based approaches, many patients with Perthes' disease are managed surgically. Positive outcome reporting, defined as reporting a study variable producing statistically significant positive (beneficial) results, is a phenomenon that can be considered a proxy for the strength of science. This study aims to conduct a systematic literature review with the hypothesis that positive outcome reporting is frequent in studies on the treatment of Perthes' disease.

Methods

We conducted a systematic review of all available abstracts associated with manuscripts in English or with English translation between January 2000 and December 2021, dealing with the treatment of Perthes' disease. Data collection included various study characteristics, surgical versus non-surgical management, treatment modality, mean follow-up time, analysis methods, and clinical recommendations.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 106 - 106
1 Apr 2017
Barrack R
Full Access

Tourniquet use in total knee arthroplasty is convenient for the surgeon and provides a bloodless field for expeditious surgery and a dry field for cementation, but can best be described as an orthopaedic tradition. It is logical for complex anatomy of ligament, nerve, and vessel surgery but it may not be necessary for total knee replacement. In one recent randomised trial, the absence of the tourniquet was not found to affect the quality of cement fixation. There are numerous potential downsides to the use of a tourniquet including decrease range of motion, delayed recovery, increased pain, wound complications, micro-emboli, neuropathy, and increased VTE. There are also a number of complications associated with the use of a tourniquet including arterial thrombosis, skin irritation below the tourniquet, post-operative hyperemia, blood loss, less accurate intra-operative assessment, and it complicates intravenous drug administration. Studies of range of motion have shown that when there is a difference noted, the range of motion is consistently better without tourniquet use. When a tourniquet is utilised it has been found to be advantageous to only use of tourniquet for a minimal amount of the case, typically when cementing is performed. Functional strength has also been found to be improved without the use of a tourniquet. This was attributed to muscle damage, tourniquet-induced ischemia, and compressive injury. Increased peri-operative pain has also been reported in randomised trials associated with the use of a tourniquet. Edema, swelling, and limb girth issues have also been noted to be associated with tourniquet use. Exsanguinating a limb will result in swelling approximately 10% of the original volume half due to a return of blood, and half due to reactive hyperemia. Longer tourniquet times are also associated with increased wound drainage and more wound hypoxia. Tourniquet use has also been associated with embolic phenomenon with several times greater risk of large emboli associated with tourniquet use. A number of complications have been associated with tourniquet use including thromboembolic complications. In one study where quantitative MRI was utilised on both thighs after unilateral total knee replacement with and without a tourniquet, the tourniquet group showed more atrophy with a loss of 20% of the volume compared to the normal side in total knees performed with a tourniquet which also performed clinically worse. There is a small but substantial risk of arterial thrombosis particularly in patients that have atherosclerotic plaque. Ironically there is a risk of increased post-operative blood loss due to the post-tourniquet “blush” as the blood pressure and pain increase hours after a surgical procedure is completed. There is also difficulty in identifying and coagulating posterior and lateral geniculate vessels with the components in place. Utilizing a tourniquet also interferes with intra-operative assessment of patella tracking, range of motion, ligament stability, and gap balancing. Randomised clinical trials have concluded that there is less pain and quicker recovery without the use of a tourniquet. There have also been reports of less swelling, increased range of motion, less analgesic use and better clinical outcome when a tourniquet is not utilised. A meta-analysis of systematic reviews favored not utilizing a tourniquet due to the decrease in complication rate and the improvement in clinical results. While it is standard practice in the US to utilise a tourniquet, the strong consensus of the literature on the subject favors either not using a tourniquet or minimizing the use of a tourniquet for the period of time necessary for a very dry field for cement fixation


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 64 - 64
1 May 2014
Rosenberg A
Full Access

The presentations to be discussed by the panel are: 1.) No Increased Risk of Knee Arthroplasty Failure in Metal Hypersensitive Patients: A Matched Cohort Study; 2.) Knee Arthrodesis is Most Likely to Control Infection and Preserve Function Following Failed 2 Stage Procedure for Treatment of Infected TKA: A Decision Tree Analysis; 3.) Does Malnutrition Correlate with Septic Failure of Hip and Knee Arthroplasties?; 4.) Diagnosing Periprosthetic Joint Infection: The Era of the Biomarker Has Arrived; 5.) Are Patient Reported Allergies a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty?; 6.) Revising an HTO or UKA to TKA: Is it more like a Primary TKA or a Revision TKA?; 7.) At 5 Years Highly-Porous-Metal Tibial Components Were Durable and Reliable: A Randomised Clinical Trial of 389 Patients; 8.) Current Data Does Not Support Routine Use of Patient-Specific Instrumentation in Total Knee Arthroplasty; 9.) Barbed vs. Standard Sutures for Closure in Total Knee Arthroplasty: A Multicenter Prospective Randomised Trial; 10.) Particles from Vitamin-E-diffused HXL UHMWPE Induce Less Osteolysis Compared to Virgin HXL UHMWPE in a Murine Calvarial Bone Model; 11.) Construct Rigidity: Keystone for Reconstructing Pelvic Discontinuity; 12.) Do You Have to Remove a Corroded Femoral Stem?; 13.) Direct Anterior Versus Mini-Posterior Total Hip Arthroplasty with the Same Advanced Pain Management and Rapid Rehabilitation Protocol: Some Surprises in Early Outcome; 14.) Adverse Clinical Outcomes in a Primary Modular Neck/Stem System


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 480 - 480
1 Sep 2012
Andersen K Christensen A Petersen M Christensen B Pedersen N Soballe K
Full Access

Background. Randomized, controlled trials (RCTs) are generally accepted as the “gold standard” for the provision of the most unbiased measures of the efficacy of interventions but are often criticized for the lack of external validity. We assessed the external validity of a RCT examining the efficacy of local infiltration analgesia (LIA) compared with continuous epidural infusion after total knee arthroplasty (TKA). Methods. During a one-year period, all patients consecutively admitted for elective, unilateral, primary TKA were identified as potential participants. All underwent eligibility screening to determine who were eligible for participation in a randomized controlled trial. We investigated the distribution of preoperative characteristics and postoperative variables among excluded patients, non-consenters, and enrolled and randomized participants. Results. In all 157 patients were identified as potential participants. Only 49 patients (31%) were enrolled and randomized. A significant difference was found in both preoperative characteristics and clinical outcome variables. Non-participants were less healthy and needed more help from the home care service than did participants. Furthermore, they were hospitalized longer. Interpretation. Our findings demonstrate the importance of reporting the results of RCTs in a way that allows clinicians to judge to whom the results can reasonably be applied


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 36 - 36
1 Nov 2016
Barrack R
Full Access

Tourniquet use in total knee arthroplasty (TKA) is convenient for the surgeon and provides a bloodless field for expeditious surgery and a dry field for cementation, but can best be described as an orthopaedic tradition. It is logical for complex anatomy of ligament, nerve, and vessel surgery but it may not be necessary for TKA. In one recent randomised trial, the absence of the tourniquet was not found to affect the quality of cement fixation. There are numerous potential downsides to the use of a tourniquet including decrease range of motion, delayed recovery, increased pain, wound complications, micro-emboli, neuropathy, and increased VTE. There are also a number of complications associated with the use of a tourniquet including arterial thrombosis, skin irritation below the tourniquet, post-operative hyperemia, blood loss, less accurate intra-operative assessment, and it complicates intravenous drug administration. Studies of range of motion have shown that when there is a difference noted, the range of motion is consistently better without tourniquet use. When a tourniquet is utilised it has been found to be advantageous to only use the tourniquet for a minimal amount of the case, typically when cementing is performed. Functional strength has also been found to be improved without the use of a tourniquet. In a recent randomised trial, tourniquet use was associated with decreased quad strength at 3 weeks that persisted at 3 months. This was attributed to muscle damage, tourniquet-induced ischemia, and compressive injury. Increased peri-operative pain has also been reported in randomised trials associated with the use of a tourniquet. Edema, swelling, and limb girth issues have also been noted to be associated with tourniquet use. Exsanguinating a limb will result in swelling approximately 10% of the original volume half due to a return of blood, and half due to reactive hyperemia. Longer tourniquet times are also associated with increased wound drainage and more wound hypoxia as measured by transcutaneous oxygen levels. Tourniquet use has also been associated with embolic phenomenon with several times greater risk of large emboli. In one study where quantitative MRI was utilised on both thighs after unilateral total knee replacement with and without a tourniquet, the tourniquet group showed more atrophy with a loss of 20% of the volume compared to the normal side in total knees performed with a tourniquet which also performed clinically worse. There is a small but substantial risk of arterial thrombosis particularly in patients that have atherosclerotic plaque. Ironically there is a risk of increased post-operative blood loss due to the post-tourniquet “blush” as the blood pressure and pain increase hours after a surgical procedure is completed. There is also difficulty in identifying and coagulating posterior and lateral geniculate vessels with the components in place. Utilizing a tourniquet also interferes with intra-operative assessment of patella tracking, range of motion, ligament stability, and gap balancing. Randomised clinical trials have concluded that there is less pain and quicker recovery without the use of a tourniquet. There have also been reports of less swelling, increased range of motion, less analgesic use and better clinical outcome when a tourniquet is not utilised. A meta-analysis of systematic reviews favored not utilizing a tourniquet due to the decrease in complication rate and the improvement in clinical results. While it is standard practice in the US to utilise a tourniquet, the strong consensus of the literature on the subject favors either not using a tourniquet or minimizing the use of a tourniquet for the period of time necessary for a very dry field for cement fixation


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 154 - 154
1 Jan 2016
Kim H Seon J Seol J Kim G Yoo S
Full Access

Background. Despite the excellent clinical success of total knee arthroplasty (TAK), controversy remains concerning whether or not to resurface the patella. This has led to a number of randomized controlled trials. Randomized controlled trials constitute the most reliable source of evidence for the evaluation of the efficacy of a potential intervention. But most of these studies include all degree of osteoarthritis of the patellofemoral joint. So we did this prospective study to compare clinical and radiological outcomes after TKA with or without patellar resurfacing in patients with grade IV osteoarthritis on patellofemoral joint. Materials and Methods. 123 cases (93 patients) with Kellgren-Lawrence grade IV osteoarthritis on patellofemoral joint were enrolled for this study. At the operating room, they were randomly assigned to undergo patella resurfacing (62 cases) or patella retention (61 cases). Among them, 114 cases that could be followed for more than 2 years were included in this study (resurfacing group; 59 cases, retention group; 55 cases). When patellar retention was performed, osteophytes of the patella were removed and marginal electrocauterization was carried out. Preoperative and postoperative clinical outcomes were evaluated and compared regarding the Hospital for Special Surgery Patellar (HSSP) score (total 100 point; anterior knee pain, functional limitation, tenderness, crepitus, Q-strength). We also compared Hospital for Special Surgery (HSS) and WOMAC scores, and range of motion (ROM). We also compared radiological outcomes at the final follow up, with regards to mechanical axis of the lower limb, patella tilt and patella congruence angle between two groups. Results. Average HSSP score was 85 in resurfacing group, 83 in retention group, which were showing no significant differences between groups (p=.75). Anterior knee pain subscale also showed no significant differences between groups (40 in resurfacing group, 36 in retention group, p= 0.52). HSS score improved to 94 points in resurfacing group and 95 points in retention group showing no significant difference (p=.92). While WOMAC score and range of motion was 32 point and 128°±10.5° in resurfacing group, respectively, they were 29 point and 126°±11.5° in retention group, without significant inter-group difference (p>.05). There were no differences between two groups in mechanical axis of the lower limb and patella tilt, patella congruence (p>0.05). Conclusion. Clinical and radiological outcomes were ‘good’ after TKA with or without patellar resurfacing in patients with high grade osteoarthritis of the patellofemoral joint without significant differences. Thus, this study suggested that TKA without patellar resurfacing is a good treatment option in patients with high grade osteoarthritis of the patellofemoral joint


Bone & Joint Open
Vol. 3, Issue 10 | Pages 741 - 745
1 Oct 2022
Baldock TE Dixon JR Koubaesh C Johansen A Eardley WGP

Aims

Patients with A1 and A2 trochanteric hip fractures represent a substantial proportion of trauma caseload, and national guidelines recommend that sliding hip screws (SHS) should be used for these injuries. Despite this, intramedullary nails (IMNs) are routinely implanted in many hospitals, at extra cost and with unproven patient outcome benefit. We have used data from the National Hip Fracture Database (NHFD) to examine the use of SHS and IMN for A1 and A2 hip fractures at a national level, and to define the cost implications of management decisions that run counter to national guidelines.

Methods

We used the NHFD to identify all operations for fixation of trochanteric fractures in England and Wales between 1 January 2021 and 31 December 2021. A uniform price band from each of three hip fracture implant manufacturers was used to set cost implications alongside variation in implant use.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 719 - 722
1 Jul 2023
Costa ML Brealey SD Perry DC

Musculoskeletal diseases are having a growing impact worldwide. It is therefore crucial to have an evidence base to most effectively and efficiently implement future health services across different healthcare systems. International trials are an opportunity to address these challenges and have many potential benefits. They are, however, complex to set up and deliver, which may impact on the efficient and timely delivery of a project. There are a number of models of how international trials are currently being delivered across a range of orthopaedic patient populations, which are discussed here. The examples given highlight that the key to overcoming these challenges is the development of trusted and equal partnerships with collaborators in each country. International trials have the potential to address a global burden of disease, and in turn optimize the benefit to patients in the collaborating countries and those with similar health services and care systems.

Cite this article: Bone Joint J 2023;105-B(7):719–722.


Bone & Joint Research
Vol. 11, Issue 12 | Pages 873 - 880
1 Dec 2022
Watanabe N Miyatake K Takada R Ogawa T Amano Y Jinno T Koga H Yoshii T Okawa A

Aims

Osteoporosis is common in total hip arthroplasty (THA) patients. It plays a substantial factor in the surgery’s outcome, and previous studies have revealed that pharmacological treatment for osteoporosis influences implant survival rate. The purpose of this study was to examine the prevalence of and treatment rates for osteoporosis prior to THA, and to explore differences in osteoporosis-related biomarkers between patients treated and untreated for osteoporosis.

Methods

This single-centre retrospective study included 398 hip joints of patients who underwent THA. Using medical records, we examined preoperative bone mineral density measures of the hip and lumbar spine using dual energy X-ray absorptiometry (DXA) scans and the medications used to treat osteoporosis at the time of admission. We also assessed the following osteoporosis-related biomarkers: tartrate-resistant acid phosphatase 5b (TRACP-5b); total procollagen type 1 amino-terminal propeptide (total P1NP); intact parathyroid hormone; and homocysteine.


Bone & Joint 360
Vol. 11, Issue 6 | Pages 15 - 18
1 Dec 2022

The December 2022 Hip & Pelvis Roundup360 looks at: Fix and replace: simultaneous fracture fixation and hip arthroplasty for acetabular fractures in older patients; Is the revision rate for femoral neck fracture lower for total hip arthroplasty than for hemiarthroplasty?; Femoral periprosthetic fractures: data from the COMPOSE cohort study; Dual-mobility cups and fracture of the femur; What’s the deal with outcomes for hip and knee arthroplasty outcomes internationally?; Osteochondral lesions of the femoral head: is costal cartilage the answer?


Bone & Joint Open
Vol. 4, Issue 9 | Pages 696 - 703
11 Sep 2023
Ormond MJ Clement ND Harder BG Farrow L Glester A

Aims

The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons.

Methods

Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims

Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this.

Methods

Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.


Bone & Joint Research
Vol. 12, Issue 2 | Pages 138 - 146
14 Feb 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims

Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years.

Methods

Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 347 - 355
15 Mar 2023
Birch NC Cheung JPY Takenaka S El Masri WS

Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents.

Cite this article: Bone Joint J 2023;105-B(4):347–355.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 324 - 334
19 Apr 2024
Phelps EE Tutton E Costa ML Achten J Gibson P Perry DC

Aims

The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures.

Methods

Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1156 - 1167
1 Oct 2022
Holleyman RJ Khan SK Charlett A Inman DS Johansen A Brown C Barnard S Fox S Baker PN Deehan D Burton P Gregson CL

Aims

Hip fracture commonly affects the frailest patients, of whom many are care-dependent, with a disproportionate risk of contracting COVID-19. We examined the impact of COVID-19 infection on hip fracture mortality in England.

Methods

We conducted a cohort study of patients with hip fracture recorded in the National Hip Fracture Database between 1 February 2019 and 31 October 2020 in England. Data were linked to Hospital Episode Statistics to quantify patient characteristics and comorbidities, Office for National Statistics mortality data, and Public Health England’s SARS-CoV-2 testing results. Multivariable Cox regression examined determinants of 90-day mortality. Excess mortality attributable to COVID-19 was quantified using Quasi-Poisson models.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 610 - 621
1 Jun 2023
Prodromidis AD Chloros GD Thivaios GC Sutton PM Pandit H Giannoudis PV Charalambous CP

Aims

Loosening of components after total knee arthroplasty (TKA) can be associated with the development of radiolucent lines (RLLs). The aim of this study was to assess the rate of formation of RLLs in the cemented original design of the ATTUNE TKA and their relationship to loosening.

Methods

A systematic search was undertaken using the Cochrane methodology in three online databases: MEDLINE, Embase, and CINAHL. Studies were screened against predetermined criteria, and data were extracted. Available National Joint Registries in the Network of Orthopaedic Registries of Europe were also screened. A random effects model meta-analysis was undertaken.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 585 - 586
1 Nov 2011
Dodwell ER Latorre JG Parisini E Zwettler E Chandra D Mulpuri K Snyder B
Full Access

Purpose: Non-steroidal anti-inflammatory drugs (NSAIDs) are powerful analgesics, frequently used for post-operative pain control. However, concerns regarding the potential deleterious effects of NSAIDs on bone healing have compelled many physicians to avoid NSAIDs in patients with fractures, osteotomies, and fusions. The purpose of this study was to systematically review and meta-analyze the best clinical evidence regarding the effects of NSAIDs on bone healing. Method: We performed a literature search for studies of fracture, osteotomy or fusion patients with NSAID exposure, and non-union as an outcome. Data on study design, patient characteristics and risk estimates were extracted. Pooled effect estimates were calculated. Study inclusion results were checked for evidence of publication bias. Metaregressions were performed to assess the impact of age, smoking, and study quality on reported risk of non-union. Results: Seven spine fusion and four long-bone fracture studies were included. A significant association between lower quality studies and higher reported odds ratios for non-union was identified. When only higher quality studies were considered, seven spine fusion studies were analyzed, and no statistically significant association between NSAID exposure and non-union was identified (OR=2.2, 95%CI:0.8, 6.3). No statistically significant association was found in sub-analysis of patients exposed to high dose IV/IM ketorolac (OR=2.0, 95%CI:0.4, 11.1), low dose IV/IM ketorolac (OR=1.2 95%CI:0.3, 4.5), or standard oral NSAIDs (OR=7.1, 95%CI:0.1, 520). In sub-analysis of the four most clinically relevant studies of adult spine fusion patients with well defined peri-operative NSAID exposure, no statistically significant association was found between NSAID exposure and risk of non-union (OR=0.8 95%CI:0.4, 1.4). Conclusion: Studies on NSAID exposure in long-bone healing settings were of lesser quality than studies in the spine fusion setting. Within the spine literature we could not demonstrate any increased risk of non-union with NSAID exposure. Randomized controlled trials (and meta-analyses of such trials) on the impact of standard NSAID and COX-2 inhibitor exposure in spine and long-bone fracture, fusion and osteotomy populations are warranted to confirm or refute the findings of this meta-analysis of observational studies


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 526 - 526
1 Aug 2008
Lakkireddi MP Gill MI Chan MJ Kotrba DM Newman-Saunders DT Marsh MG
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Background: The major problem achieving lumbar spinal fusion is developing pseudarthrosis. At present the gold standard in achieving fusion is the use of autograft from pelvis or posterior elements of the spine. However the potential limitations of insuffient quantity and donor site morbidity have led to search for bone graft alternatives like DBM which contains osteinductive BMPs. Aims & Methods: A Prospective Randomized Control trial comparing the effectiveness of demineralised Bone Matrix (DBM Putty)/autograft composite with autograft in lumbar spinal fusion. 35 patients were included in the trial; they were randomized to have DBM and autograft on one side, and autograft alone on other side to side. Patients were followed up with interval radiographs for total of 24mons. To date 20 patients have completed minimum 12mons follow up. The mineralization of fusion mass lateral to the instrumentation on each side was graded Absent, Mild (< 50%), Moderate (> 50%) or Complete fusion (100%). The assessment was made by two orthopaedic consultants and a musculoskeletal radiologist who were blinded to graft assignment. Results: The sex distribution was 11:9 male to females with a mean age of 55.2 (21–87 years) and an average follow up of 18mons (12–24mons). Nine patients had single level fusion and the remainder had more than one level fusion. At 12 months on the side of DBM, 15% (6 of 20) had complete fusion, 80% (16 of 20) had moderate fusion, and 5% had no fusion mass. During the same period on the other side, 25% did not show any sign of fusion. There was no correlation with number of levels, age or sex. Conclusions: Osteoinductive properties of DBM would appear to help in achieving early and higher union rates in lumbar spinal fusion. DBM reduces the amount of harvested autograft graft and also minimises the morbidity of donor site complications


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 284 - 284
1 Sep 2012
Wendlandt R Schrader S Schulz A Spuck S Jürgens C Tronnier V
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Introduction. The degeneration of the adjacent segment in lumbar spine with spondylodesis is well known, though the exact incidence and the mechanism is not clear. Several implants with semi rigid or dynamic behavior are available to reduce the biomechanical loads and to prevent an adjacent segment disease (ASD). Randomized controlled trials are not published. We investigated the biomechanical influence of dynamic and semi rigid implants on the adjacent segment in cadaver lumbar spine with monosegmental fusion (MF). Materials and Methods. 14 fresh cadaver lumbar spines were prepared; capsules and ligaments were kept intact. Pure rotanional moments of ±7.5 Nm were applied with a Zwick 1456 universal testing machine without preload in lateral bending and flexion/extension. The intradiscal pressure (IDP) and the range of motion (ROM) were measured in the segments L2/3 and L3/4 in following situations: in the native spine, monosegmental fusion L4/5 (MF), MF with dynamic rod to L3/4 (Dynabolt), MF with interspinous implant L3/4 (Coflex), and semi rigid fusion with PEEK rod (CD Horizon Legacy) L3-L5. Results. Under flexion load all implants reduced the IDP of segment L2/L3, whereas the IDP in the segment L3/4 was increased using interspinous implants in comparison to the other groups. The IDP was reduced in extension in both segments for all semi rigid or dynamic implants. Compared under extension to the native spine the MF had no influence on the IDP of the adjacent disc. The rod instrumentation (Dynabolt, PEEK rod) lead to a decreased IDP in lateral bending tests. The ROM in L3 was reduced in all groups compared to the native spine. The dynamic and semi rigid stabilization in the segment L3/4 limited the ROM more than the MF. Discussion. The MF reduced the ROM in all directions, whereas the IDP of the adjacent segment remained unaffected. The support of the adjacent segment by semi rigid and dynamic implants decreased the IDP of both segments in extension mainly. This fact is an agreement with other studies. Compared to our data, no significant effect on the adjacent levels was observed. Interestingly, in our study, the IDP of the adjacent segment is unaffected by MF. The biomechanical influence in the view of an ASD could be comprehended, but is not completely clear. The fact of persistent IDP in the adjacent segment suggests that MF has a lower effect on the adjacent segment degeneration as presumed. Biomechanical studies with human cadaver lumbar spines are limited and depend on age and degenerative situation. The effect on supporting implants on adjacent segment disease in lumbar spine surgery has to be investigated in clinical long term studies


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 485 - 485
1 Aug 2008
Karjalainen K
Full Access

Study design: Randomized controlled trial. Objectives: To investigate the long-term effectiveness, costs, and effect modifiers of a mini-intervention, provided in addition to the usual care, and the incremental effect of a worksite visit for patients with subacute disabling low back pain (LBP). Methods: 164 subacute LBP patients randomized into a mini-intervention (A, n=56), a mini-intervention plus a worksite visit (B, n=51) or the usual care (C, n=57). Mini-intervention consisted of a detailed assessment of the patients’ history, beliefs and physical findings by a physician and a physiotherapist, followed by recommendations and advice. The usual care patients received the conventional care. Pain, disability, health-related quality of life, satisfaction with care, days on sick leave, and health care consumption and costs were measured during a 24-month follow-up. Thirteen candidate modifiers were tested for each outcome. Results: There were no differences between the three treatment arms regarding the intensity of pain, the perceived disability or the health-related quality of life. However, mini-intervention decreased occurrence of daily (A vs, C, P=0.01) and bothersome (A vs C, P< 0.05) pain and increased treatment satisfaction. Costs resulting from LBP were lower in the intervention groups (A 4670 €, B 5990 €) than in C (C 9510 €) (A vs. C, p=0.04 and B vs. C, n.s). The average number of days on sick leave was 30 in A, 45 in B and 62 in C (A vs. C, p=0.03, B vs. C, n.s). The perceived risk for not recovering was the strongest modifier of treatment effect. Mental & mental-physical workers in A and B were less often on sick leave than those in C. Conclusions: Mini-intervention is an effective treatment for subacute LBP. Despite lack of a significant effect on intensity of low back pain and perceived disability, mini-intervention including proper recommendations and advice, according to the “active approach”, is able to reduce LBP-related costs. The perceived risk of not recovering was the strongest modifier of treatment effect. In alleviating pain the intervention was most effective among the patients with a high perceived risk of not recovering


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 206 - 211
1 Feb 2022
Bloch BV White JJE Matar HE Berber R Manktelow ARJ

Aims

Total hip arthroplasty (THA) is a very successful and cost-effective operation, yet debate continues about the optimum fixation philosophy in different age groups. The concept of the 'cementless paradox' and the UK 'Getting it Right First Time' initiative encourage increased use of cemented fixation due to purported lower revision rates, especially in elderly patients, and decreased cost.

Methods

In a high-volume, tertiary referral centre, we identified 10,112 THAs from a prospectively collected database, including 1,699 cemented THAs, 5,782 hybrid THAs, and 2,631 cementless THAs. The endpoint was revision for any reason. Secondary analysis included examination of implant survivorship in patients aged over 70 years, over 75 years, and over 80 years at primary THA.