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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 71 - 71
1 Oct 2019
Howard JL Zomar B Marsh JD Bryant D Lanting BA
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Introduction

Total hip arthroplasty (THA) is an effective surgery for the treatment of advanced osteoarthritis but increasing numbers of these procedures are having a significant impact on healthcare budgets. One route to mitigate the increasing costs is outpatient THA, discharging patients on the same day as their surgery. The purpose of this study was to determine the cost of outpatient THA compared to standard overnight stay in hospital.

Methods

This was a prospective-randomized controlled trial for patients undergoing primary THA through a direct anterior approach. Participants were randomized to be discharged on the same day as surgery, as outpatients, or on day one post-surgery, as inpatients, using a Zelen consent model. Adverse events were assessed, and participants completed self-reported cost questionnaires at two-, six- and 12-weeks post-surgery, and the WOMAC preoperatively and at 12-weeks post-surgery. We performed a cost analysis from health care payer (HCP) and societal perspectives.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 21 - 21
1 Aug 2020
Somerville L Zomar B Vasarhelyi E Lanting B Howard J Marsh J
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Total knee arthroplasty is a successful procedure that reduces knee pain and improves function in most patients with knee osteoarthritis. Patient dissatisfaction however remains high, and along with implant longevity, may be affected by component positioning. Surgery in obese patients is more technically challenging with difficulty identifying appropriate landmarks for alignment and more difficult exposure of the joint. Patient specific instrumentation (PSI) has been introduced with the goal to increase accuracy of component positioning by custom fitting cutting guides to the patient using advanced imaging. A strong criticism of this new technology however, is the cost associated. The purpose of this study was to determine, using a prospective, randomized-controlled trial, the cost-effectiveness of PSI compared to standard instrumentation for total knee arthroplasty in an obese patient population.

Patients with a body mass index greater than 30 with osteoarthritis and undergoing a primary total knee arthroplasty were included in this study. We randomized patients to have their procedure with either standard instrumentation (SOC) or PSI. At 12-weeks post-surgery patients completed a self-reported cost questionnaire and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). We performed a cost-effectiveness analyses from a public health payer and societal perspective. As we do not know the true cost of the PSI instrumentation, we estimated a value of $100 for our base case analysis and used one-way sensitivity analyses to determine the effect of different values (ranging from $0 to $500) would have on our conclusions.

A total of 173 patients were enrolled in the study with 86 patients randomized to the PSI group and 87 to the SOC group. We found the PSI group to be both less effective and more costly than SOC when using a public payer perspective, regardless of the cost of the PSI. From a societal perspective, PSI was both less costly, but also less effective, regardless of the cost of the PSI. The mean difference in effect between the two groups was −1.61 (95% CI −3.48, 026, p=0.091). The incremental cost-effectiveness ratio was $485.71 per point increase in the WOMAC, or $7285.58 per clinically meaningful difference (15 points) in the WOMAC.

Overall, our results suggest that PSI is not cost-effective compared to standard of care from a public payer perspective. From a societal perspective, there is some question as to whether the decreased effect found with the PSI group is worth the reduced cost. The main driver of the cost difference appears to be time off of volunteer work, which will need to be investigated further. In future, we will continue to follow these patients out to one year to collect cost and effectiveness data to investigate whether these results remain past 12 weeks post-surgery.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_4 | Pages 4 - 4
8 Feb 2024
Oliver WM Bell KR Carter TH White TO Clement ND Duckworth AD Molyneux SG
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This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture.

70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL).

At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups.

Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 9 - 9
1 May 2019
Dasaraju P Parker M
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Continued controversy exists between cemented versus uncemented hemiarthroplasty for an intracapsular hip fracture. To assist in resolving this controversy, 400 patients were randomised between a cemented polished tapered stem hemiarthroplasty and an uncemented Furlong hydroxyapatite coated hemiarthroplasty. Follow-up was by a nurse blinded to the implant used for up to three years from surgery.

Results indicate no difference in the pain scores between implants but a tendency to an improved regain of mobility for those treated with the cemented arthroplasty (1.2 score versus 1.7 at 6 months, p=0.03). There was no difference in early mortality but a tendency to a higher later mortality for the uncemented implants (29% versus 24% at one year, p=0.3). Later peri-prosthetic fracture was more common in the uncemented group (3% versus 1.5%). Revision arthroplasty was required for 2% of cemented cases and 3% of uncemented cases. Surgery for an uncemented hemiarthroplasty was 5 minutes shorter but these patients were more likely to need a blood transfusion (14% versus 7%). Three patients in the cemented group had a major adverse reaction to bone cement leading to their death.

These results indicated that a cemented stem hemiarthroplasty give marginally improved regain of mobility in comparison to a contemporary uncemented hemiarthroplasty. An uncemented hemiarthroplasty still has a place for those considered to be at a high risk of bone cement implantation syndrome.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 18 - 18
1 Oct 2019
Jennings JM Mejia M Williams MA Johnson RM Yang CC Dennis DA
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Background

Optimal perioperative fluid management has not been established in patients undergoing orthopaedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management on patients experiencing TKA.

Methods

One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs. oral (OFG) perioperative fluid management groups. The TFG had a predetermined (4L) amount of intravenous fluids (IVF) administered in the perioperative period. The OFG began drinking a minimum of three, 20-ounces servings of clear fluids daily for three days prior to surgery. This cohort also drank 10-ounces of clear fluids 4 hours prior to surgery. Perioperative IVF were discontinued when the patient began oral intake or when the total amount of IVF reached 500mL. Outcome measures included: body-weight (BW) fluctuations, knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, KOOS JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 111 - 111
1 Feb 2020
Jennings J Mejia M Williams M Yang C Dennis D
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BACKGROUND

Optimal perioperative fluid management has not been established in patients undergoing orthopaedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management on patients experiencing TKA.

METHODS

One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs. oral (OFG) perioperative fluid management groups. The TFG had a predetermined amount of intravenous fluids (IVF) administered in the perioperative period. The OFG began drinking a minimum of three, 20-ounces servings of clear fluids daily for three days prior to surgery. This cohort also drank 10-ounces of clear fluids 4 hours prior to surgery. Perioperative IVF were discontinued when the patient began oral intake or when the total amount of IVF reached 500mL. Outcome measures included: body-weight (BW) fluctuations, knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, KOOS JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 33 - 33
1 Aug 2018
Waddell J Atrey A Wolfstadt J Khoshbin A Ward S
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A randomized trial was designed to compare the outcome of ceramic-on-ceramic with ceramic on conventional polyethylene. These patients have been followed for 15 years.

58 hips in 57 patients under 60 years of age were randomized into one of two groups. Patients were blinded to the type of hip they received. Both groups of patients were treated routinely with prophylactic peri-operative antibiotics and low molecular weight Heparin. All patients were seen at six weeks, three months and annually after surgery. Clinical and radiologic assessment was carried out at each visit.

Fifty-eight hips were available for analysis, 28 in the CoP group and 29 patients in the CoC group. Mean age of both groups was less than 45 years.

There were seven revisions (16%) among the 58 patients enrolled in the study. In the CoP group four patients underwent revision with head and liner exchange for eccentric polyethylene wear 16 years post-implantation. In the CoC group one patient had a cup revision at 15 years for acute aseptic instability of the acetabulum; two additional patients in the CoC group had femoral head exchange, one for fracture and one for trunnion corrosion. Both occurred 14 years after the index surgery.

Functional outcome scores showed no difference between the two groups at 15 years. Radiographically there was a statistically difference in wear between the two groups.

This study demonstrates that both ceramic-on-ceramic and ceramic-on-polyethylene produce satisfactory functional results with low revision rates in young patients.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 132 - 132
1 Feb 2020
Paglia A Goderecci R Calvisi V
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Introduction

Functional outcomes of mechanically aligned (MA) total knee arthroplasty have plateaued. The aim of this study is to find an alternative technique for implant positioning that improves functional outcomes of TKA.

Methods

We prospectively randomized 100 consecutive patients undergoing TKA into two groups: in the group A an intramedullary femoral guide and an extramedullary tibial guide were used with aim to obtain a neutral traditional mechanical alignment; in the group B an extramedullary femoral guide set on distal femoral condyles and an extramedullary tibial guide neutrally aligned were used to obtain an adaptation of the conventional MA technique.

Patients were followed-up clinically with the Short Form Health Survey (SF-12), Oxford Knee Score (OKS) and Visual Analogue Score (VAS) questionnaires pre-operatively and then at 1 year post-operatively. Mechanical alignment was calculated on standing weight bearing Xray pre- and post-operatively.

T-test was used to compare the results between groups.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 15 - 15
1 May 2019
Heaver C Hyne M Kuiper J Lewthwaite S Burston B Banerjee R
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Background

Greater trochanteric pain syndrome (GTPS) is a common problem affecting 10–25% of the population. Physiotherapy, anti-inflammatories, corticosteroid injections and surgery have all been described in the management of GTPS, all with limited, temporal success. Extracorporeal shockwave therapy (ESWT) has been proposed as a potential management option for this difficult presentation.

Method

We ran a prospective, 2 arm, single blinded, randomised control trial comparing focused shockwave therapy to an ultrasound guided corticosteroid injection. The primary outcome measure was the visual analogue pain score. Secondary outcome measures included the Harris hip score and Trendelenburg test for function; the SF-36 for quality of life (QoL); and a Likert scale question for a subjective assessment of symptom improvement.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 70 - 70
1 Oct 2019
Greenky M McGrath M Levicoff EA Good RP Nguyen J Makhdom AM Lonner JH
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Introduction

Controlling post-operative pain and reducing opioid requirements after total knee arthroplasty (TKA) remains a challenge, particularly in an era stressing rapid recovery protocols and early discharge. A single shot adductor canal block (ACB) has been shown to be effective in decreasing post-operative pain. This requires a specialty-trained Anesthesiologist skilled in ultrasound techniques, which imposes cost, time and skill barriers. Cadaveric studies and magnetic resonance imaging data have shown that access to the adductor canal is possible from within the joint, and thus the potential for intraoperative, intra-articular, surgeon administered ACB through a standard surgical approach is a feasible alternative to ultrasound guided ACB at the time of TKA. The purpose of the present study is to compare the efficacy of surgeon administered intraoperative ACB to anesthesiologist administered ACB.

Methods

Patients' undergoing primary TKA were prospectively randomized to receive either an Anesthesiologist administered (Group 1) or Surgeon administered (Group 2) ACB using 15 ml of Ropivacaine 0.5%, both in conjunction with spinal anesthesia. Perioperative multimodal anesthesia was standardized for the two groups. Primary outcomes were pain visual analogue scale (VAS), range of motion, and opioid consumption. Secondary outcomes were patient satisfaction scores and length of stay (LOS).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 55 - 55
1 Oct 2018
Jennings JM Loyd BJ Miner T Yang CC Stevens-Lapsley J Dennis DA
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Introduction

Closed suction intraarticular drain (CSD) use after total knee arthroplasty (TKA) has been studied with regards to wound healing and range of motion, however, no data exist on how CSD use impacts knee joint effusion and quadriceps strength. The primary purpose of this study was to determine whether CSD use influences recovery of quadriceps strength. Secondary outcomes examined effects of CSD on intraarticular effusion, lower limb swelling, knee range of motion (ROM), pain and wound healing complications.

Methods

Twenty-nine patients undergoing same-day bilateral TKA were enrolled in a prospective, randomized blinded study. Subjects were randomized to receive a CSD on one lower extremity while the contralateral limb had the use of a subcutaneous drain (SCDRN) without the use of suction. Isometric quadriceps strength was collected as the primary outcome. Secondary outcomes consisted of quadriceps muscle activation, intraarticular effusion measured via ultrasound, lower extremity swelling measured with bioelectrical impendence, lower extremity girth, ROM, and pain. Outcomes were assessed preoperatively and postoperatively at day 2, 2 and 6 weeks and 3 months. Differences in limbs were determined using paired t-tests or Wilcoxon signed rank tests.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_16 | Pages 134 - 134
1 Nov 2018
Murchú SÓ Goel R Sydnor K Rondon A Purtill JJ Austin MS
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The use of a tourniquet during total knee arthroplasty (TKA) is controversial. Return to function and pain are believed to be affected by the use of a tourniquet. The hypothesis of this study was that use of a tourniquet (T) would delay postoperative functional recovery and increase pain as compared to no tourniquet use (NT). 200 patients were recruited for this prospective, double-blinded, randomized controlled trial. All surgeries were performed by one of two fellowship trained arthroplasty surgeons at our institution. Patients were randomized to either undergo TKA with T or NT and blinded to group allocation. An otherwise standardized perioperative protocol was followed. The primary outcome measures were functional assessment testing using the timed up-and-go (TUG) and stair-climb (SC) tests and visual analog scale pain (VAS-P) scores. Secondary outcome measures included blood loss and range-of-motion (ROM). Patients completed outcomes measures preoperatively, in hospital, and postoperatively at 4–6 weeks and 6–8 months. Minimal detectable change (MDC) and Student's T-test, alpha of p < 0.05, were used to determine significance. No significant differences were seen in postoperative TUG, SC, VAS-P, or ROM at any time point. NT patients were seen to have significantly more calculated blood loss (means: T 1,370.04mL, NT 1,743.85mL; p < 0.001), without a significant increase in transfusion events. Tourniquet use during TKA significantly decreases blood loss and does not adversely affect early postoperative outcomes. Tourniquet use during routine TKA is safe and effective and concerns over deleterious effects on function and pain may not be justified.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 518 - 518
1 Oct 2010
Holubowycz O Howie D Middleton R
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Early revision is an important risk factor for repeated revision and poor results after primary total hip replacement and instability is a major cause of early revision. Larger articulations with cross-linked polyethylene are proposed as a solution, but these are not without risk, including fracture of the thin polyethylene rim of the liner. The aim of our study was to examine implant-related revisions among primary total hip replacement patients with up to six year follow-up in a randomized controlled trial which compared 28 mm and 36 mm metal on highly cross-linked polyethylene articulations in total hip replacement.

557 patients undergoing primary total hip replacement were included in this study. Risk factors for dislocation and wear were controlled by stratification and patients were then randomized intra-operatively to either a 28 or 36 mm articulation.

To date, 10 hips have been revised for implant-related problems following primary total hip replacement. Seven hips with a 28 mm articulation were revised to a larger articulation because of instability. Four of these were for recurrent dislocation, one for an irreduceable first dislocation and two for subluxation. In contrast, only one patient who had undergone total hip replacement with a 36 mm articulation was revised for recurrent dislocation. One hip with a 36 mm articulation in a well-positioned cup was revised to a 32 mm articulation because of elevated lip liner fracture. Another 36 mm articulation hip was revised for acetabular component loosening.

This study shows that a 36 mm metal on highly cross-linked polyethylene articulation reduces the need for early revision for instability after primary total hip replacement. However, these benefits need to be weighed against the potential risks associated with these articulations, including rare fracture of the relatively thin poly-ethylene liner.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 533 - 533
1 Oct 2010
Witzleb W Guenther K Krummenauer F Reinhart S Stephan L Wojciechowski C
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Background: Currently, total hip replacement (THR) is most commonly performed via a posterior or a direct lateral approach. We compared the one year postoperative outcome of cementless THR using the both approaches in a prospective, randomized trial.

Methods: A prospective 1:1 randomization scheme was implemented to allocate 60 patients with unilateral osteoarthritis. Patients in the lateral approach group were in median 59 years old, in 50% female and had a median BMI of 27 kg/m2 versus in median 55 years, 47% females and a median BMI of 29 kg/m2 in the posterior approach group. Outcome assessment was performed one day before surgery and 3 months, 6 months and one year after surgery, respectively, using the intra-individual Harris Hip score (HHS) improvement at one year as primary objective. Sample size calculation was based on the assumption of a minimum clinically relevant difference of 5 points and a standard deviation of 6 points in the HHS total score. WOMAC and SF-36 served as secondary objectives.

Results: Patients started with a median HHS of 50 points after lateral approach versus 46 points after posterior approach and showed a median HHS of 95 points versus 94 points one year after surgery. We found a slight tendency towards the posterior approach, but no significant difference in the intraindividual HHS improvement at all the pre- and post-operative assessment points between both treatment groups (Wilcoxon p=0.115 at 3 months, p=0.191 at 6 months and p=0.207 at one year). A comparable tendency was found in the intraindividual WOMAC improvement without statistical significance (Wilcoxon p=0.749). In contrast the SF-36 physical scales were slightly but again not significantly better after lateral approach at the one year assessment (86% versus 80%,Wilcoxon p=0.674).

Conclusions: Not any (algo-) functional and psychometric endpoint investigated showed a statistical significant difference between patients after lateral versus posterior approach for THR.

We conclude that motivation and other patient related factors, the implant and the surgeon itself influence the result much more than the approach used for total hip replacement.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 71 - 71
1 Mar 2009
Peters K Bolder H Tetteroo R
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Introduction: The short-term functional recovery after a total knee arthroplasty (TKA) is largely dependent on initial wound healing. Haematoma formation may lead to prolonged wound drainage and tissue necrosis, which can have a negative effect on early range of motion, post-operative pain and infection rate.

To decrease haematoma formation, primary soft tissue homeostasis and adequate tissue repair are essential. Growth factors, especially PDGF (platelet derived growth factor) and TGF-β (transforming growth factor-beta), play a crucial role in the biochemical cascade at the site of repair. These growth factors are mostly derived from platelets.

The objective of this study was to evaluate the effect of autologous platelet concentrate on blood loss (postoperative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.

Method: 96 patients undergoing primary total knee arthroplasty were included and randomized in two groups. In the study group, autologous platelet concentrate was applied at wound closure. Treatment with autologous platelet concentrate involves direct application of concentrated platelets, growth factors and fibrin in the operation wound. A small volume (55–110 ml) of the patient’s own blood is taken to derive a platelet rich gel which can be sprayed directly into the wound.

The peri-operative haemoglobin concentration, peri-operative range of motion, haematoma formation, number of days of wound drainage and complications were collected. The pain score (VAS), IKSS, 12 questionaire score and SF-36 score were recorded at regular intervals.

Results: There was no significant difference between the groups in post-operative haemoglobin decrease, range of motion, haematoma formation, wound drainage or pain scores. In the study group there were 3 deep infections. In the control group we had no infections.

Conclusion: We found no benefit in the use of autologous platelet concentrate in total knee arthroplasty. Furthermore, it is of concern that we had three deep infections with use of the autologous platelet concentrate.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 524 - 524
1 Aug 2008
Newsome R Chiverton N Cole A
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Study Design. Randomized, single blind, Quasi-experimental trial.

Objective. To investigate whether immediate physiotherapy post lumbar micro-discectomy enables patients to become independently mobile more rapidly with no increase in risk of complications

Summary of Background Data. Although studies have demonstrated the efficacy of rehabilitation post lumbar discectomy, none have looked at physiotherapy commencing immediately post operatively.

Methods. A total of thirty patients were randomized to an immediate group commencing physiotherapy within two hours post-operatively or a control group receiving physiotherapy first day post-operatively. Outcome measures included the time taken for the patient to become independently mobile post-surgery, Oswestry Disability Index and pain scores (VAS and short form McGill) collected pre-operatively, post-operatively at four weeks, and three months.

Results. The results indicated significantly reduced time to independent mobility (p=0.009) and return to work (p=0.002) in the immediate group. There was no significant difference in disability and pain scores at four weeks and three months between the groups. Early mobilisation did not result in increased complications.

Conclusions. Immediate physiotherapy following first time single level lumbar micro-discectomy enables patients to become independently mobile more rapidly and return to work sooner. Immediate physiotherapy may enable patients to experience earlier discharge with associated cost benefits to healthcare.


Introduction

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty (TKA). A variety of highly cross-linked polyethylenes (XLPs) have been introduced to address this problem, but there are few data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. We have previously reported an interim analysis of a study comparing polyethylene tibial liners.

Methods

This is a prospective randomized study of one modular posterior-stabilized total knee arthroplasty by a single surgeon. 265 patients (329 knees) were randomized to receive a standard compression molded liner (SP) or a highly cross-linked (6.5 CGy electron-beam irradiated and remelted) polyethylene liner (XLP). Patients were evaluated clinically using the classic Knee Society scores, LEAS score, presence of a knee effusion, and by standard radiographs for radiolucent lines and osteolytic lesions. The analysis was performed at a mean of 6 years (range, 2–11 years).


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 227 - 227
1 Mar 2004
Victor J Hoste D
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Aims: The aim of the study was to determine the accuracy of the kinematical determination of the centre of rotation of the hip and to compare the outcome of the Computer assisted surgery (CAS) group versus a control group of patients with conventionally instrumented TKA, in a prospective randomized way. Methods: A prospective, randomized and controlled trial was undertaken with an image based CAS system (ION®), using specific knee software for the GENESIS II®total knee system. Randomization was performed on a consecutive group of 50 primary TKA’s, without exclusion criteria. All computed kinematical centres of rotation of the hip were compared to the anatomic fluoroscopic images. The difference between the kinematical centre of rotation and the anatomic centre of the femoral head was measured in the frontal plane. Coronal alignment was measured on full leg standing films. Validation of the full leg standing films was carried out in comparing the pre-operative measured angle and the computed deformity angle at the beginning of the surgery. Outcome of the CAS group was compared to the conventional group on the following items: tourniquet time, operative time, blood loss, patellar alignment, tibial slope, coronal alignment, range of motion and complications. Results: ACCURACY: The correlation index between pre-op full legs and CAS measured values was excellent: r2=0.997. Difference between kinematical centre of rotation and anatomic centre of the hip: mean deviation between the two points was 1.2 mm (0–4mm), stdv 1.2 mm. This corresponds with a mean angular deviation of 0.17° (0–0.57°). OUTCOME: Tourniquet time: conventional 56 min., CAS 72 min. p=0.002. Operative time: conventional 70 min., CAS 93 min. p< 0.001. Blood loss: conventional 3.3 g/dl, CAS 4 g/dl. Patellar alignment: no tilt > 5°, no subluxation > 3 mm, both groups. Tibial slope: conventional 3.5°, CAS 3°. Post-operative mechanical alignment was between 0 and 2° of deformity for 16 conventional knees, and between 3–4° for 5 conventional knees. In the CAS group, all 21 knees scored between 0° and 2° of mechanical alignment. ROM at 6 weeks: flexion conventional 106°, CAS 105°. Fixed flexion contracture: conventional 2.9, CAS 2.1. Complications: delayed wound healing: conventional 2, CAS 1. Conclusions: Computer assisted kinematical determination of the centre of the hip can be highly accurate. Post-operative coronal alignment in CAS group is excellent, however not significantly better than conventional instrumentation.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 55 - 55
1 Oct 2019
Young SW Clarke HD Moore GA Zhang M Probst NE Spangehl MJ
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Introduction

Intraosseous administration of low dose vancomycin has been proven to produce 6 to 20 times higher tissue concentrations compared to intravenous administration in both primary and revision knee replacement. However, these superior levels are achieved when the antibiotic given intraosseously is administered distal to a tourniquet that is inflated for the majority of the case. With increasing interest in limited, or no, tourniquet use during TKA we sought to study the tissue concentrations achieved with limited tourniquet use and intraosseously administered vancomycin compared to weight-based, time optimized intravenous administration.

Methods

Twenty-four patients undergoing primary TKA were randomized to two groups. The Intravenous (IV) Group received weight based (15mg/kg) vancomycin timed to finish before incision. The Intraosseous (IO) Group received 500 mg of vancomycin injected as a bolus through a needle into the proximal tibia distal to an inflated tourniquet prior to skin incision. In the IO group, the tourniquet was deflated 10 minutes following the injection and re-inflated only for cementation. In the IV group, the tourniquet was only inflated for cementation. During the procedure, fat and bone samples were taken at regular intervals. Tissue antibiotic concentrations were measured using a validated technique involving high performance liquid chromatography.


The primary aim of this study was to determine dislocation and revision total hip replacement (THR) up to ten years following primary THR, as well as rates of polyethylene wear, in patients previously enrolled in a randomised controlled trial (RCT) which compared 28 mm and 36 mm metal on highly cross-linked polyethylene (XLPE) articulations.

328 primary THR patients were enrolled in the RCT in Australia. Dislocation was identified from hip instability and hospital visit questionnaires completed by patients or, if they were unable to do so, by their next of kin or primary carer, or General Practitioner. All reported dislocations were confirmed radiographically. Patients' names were cross-matched with the Australian National Joint Replacement Registry to determine whether the index hip had undergone revision THR. Linear wear was measured on plain radiographs using PolyWare (Rev 5, Draftware Developers, Vevay IN, USA). A separate RCT examined the mean proximal wear rate of 28 and 36 mm articulations using radiostereometric analysis (RSA).

At 10 years, 110 patients were deceased and 3 patients were lost to follow-up. Overall, dislocation was identified in 8 of 167 (5%) patients with a 28 mm articulation and 2 of 158 (1%) patients with a 36 mm articulation. Three patients experienced recurrent dislocation; all had a 28 mm articulation. 320 (163 28 mm; 157 36 mm) patients were successfully cross-matched with Registry data to identify revision THR. Three patients, all with a 28 mm articulation, underwent revision because of dislocation. Other reasons for revision were infection (1:2), periprosthetic fracture (0:3), loosening/lysis (1:2) and liner fracture (0:1). Adequate radiographs were available to measure wear in 122 hips (67:55) using PolyWare. Excluding bedding in, the mean annual linear wear rate from 1–10 years was 0.04 mm/yr for both 28 and 36 mm articulations (p=0.48). The more sensitive RSA data indicated that at 7 years following primary THR, the mean annual wear rate did not exceed 0.02 mm/yr with either articulation.

Up to 10 years following primary THR, 36 mmm articulations were associated with fewer dislocations and revisions for dislocation and did not increase the mean annual linear wear rate.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 525 - 525
1 Sep 2012
Kumar V Garg B Malhotra R
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Introduction

We compared standard NexGen Cruciate substituting-flex prosthesis with gender-specific NexGen Cruciate substituting flex prosthesis in patients undergoing bilateral total knee arthroplasty with regard to Coverage of the bone by femoral component, Clinical outcome, Radiographic outcome, Survival and complication rates, with special emphasis on patellofemoral complications.

Material & Methods

30 female patients with osteo-arthritis of the knees with similar deformity and preoperative range of motion were randomized to have one knee replaced with a gender non-specific Nexgen Cruciate substituting (Zimmer) prosthesis and the other with Gender Cruciate substituting (Zimmer) prosthesis. Follow-up clinical evaluation was done at 6, and 12 months postoperatively and then at yearly interval using “Knee Society” Recommendations. Clinical assessment of the patellofemoral joint of the replaced knees was done with the help of “Hospital for Special Surgery” patellar scoring system. The overall patient satisfaction after surgery was evaluated with use of the British Orthopaedic Association patient satisfaction score.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 290 - 290
1 Jul 2011
Dewan P Batta V Khan P Prabhakar H
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Background: Traditionally, lumbar discectomy is performed under general anaesthesia because of ability to perform operations of long duration in prone position with a secure airway. Some recent reports suggest better outcomes with regional anaesthesia.

Aim: The aim of this study was to compare the intra-operative and short-term post-operative outcome variables in patients undergoing primary single-level lumbar discectomy with epidural and general anaesthesia.

Methods: This was a prospective randomized trial involving sixty patients over a two-year period in a tertiary hospital in India. Patients were allocated into two groups: Group A (n=30) patients received general anaesthesia and Group B (n=30) patients received epidural anaesthesia. Baseline and intra-operative haemodynamic parameters, surgical duration, surgical onset time, intra-operative blood loss, cost incurred by patient, nausea and vomiting and post-operative pain score were also recorded.

Results: The groups were comparable for demographic data and baseline hemodynamic observations. Patients in the epidural anaesthesia group had significantly lower blood loss (p< 0.001), lower peak pain scores (p< 0.001), lesser surgical time (p< 0.001),and significantly reduced post-operative nausea and vomiting (p< 0.01) as compared to the general anaesthesia group. The cost incurred for epidural anaesthesia was two third of that incurred in general anaesthesia (p< 0.001). Epidural group had significantly more surgical onset time (p< 0.001)

Conclusion: Lumbar discectomy can be safely performed using epidural anaesthesia. The intra-operative blood loss, surgical duration, cost incurred by the patient, postoperative nausea, vomiting and pain are significantly reduced in patients receiving epidural anaesthesia, thereby leading to a significantly higher patient satisfaction. In the present climate of NHS, where any initiative to cut down the cost of resources consumed is welcomed as long as the patient safety is not compromised, epidural anaesthetic may provide an effective alternative to general anaesthetic for lumbar discectomy.


Though there are many techniques utilised in the correction of hallux valgus (HV), no single approach has been reported to be ideal for all patients to date. A great deal of controversy remains concerning the type of osteotomy, method of fixation, and inclusion of soft tissue procedures. Herein, we compared the outcomes of two different operative techniques, the minimally-invasive modified percutaneous technique and the distal chevron osteotomy, used to treat mild to moderate hallux valgus. This study was conducted in line with the CONSORT 2010 guidelines. 41 patients (58 feet) with mild to moderate hallux valgus were randomly assigned by computer to two different groups. The first group containing 24 patients (33 feet) was treated by the modified percutaneous technique, whereas the second group included 17 patients (25 feet) treated by distal chevron osteotomy. In the modified percutaneous group, after a mean follow up of 43 months, the mean correction of hallux valgus angle (HVA) was 26.69° (P=0.00001), the mean correction of intermetatarsal angle (IMA) was 9.45° (P=0.00001), and the mean improvement of AOFAS score was 47.94 points (P=0.00001). In the chevron osteotomy group, after a mean follow up of 44 months, the mean correction of hallux valgus angle was 26.72° (P=0.00001), the mean correction of intermetatarsal angle was 9° (P=0.00001), and the mean improvement of AOFAS score was 44.76 points (P=0.00001). In our study, the modified percutaneous technique proved to be equally effective as the distal chevron osteotomy, but with fewer complications and a higher rate of patient satisfaction.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 241 - 241
1 Mar 2010
Mahajan R Dalal R Cullen C
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Introduction: We present the results of a controlled randomized trial of the use of a popliteal block for pain relief in ankle and hindfoot surgery.

Materials and methods: We studied 47 patients over period of nine months in 2007 to 2008. Patients undergoing an ankle or hindfoot procedure were included in the trial. The trial was explained to the patients. Written information leaflets were also used in the preoperative clinics. Patients were randomized on the day of surgery. A sealed envelope randomizing the patient to block (A), or no block (B) was opened in the anaesthetic room before the patient was anaesthetised. Patients were subjective pain scores were recorded at 30 min, 6, 12 and 24 hours after surgery. The amount of analgesia required and time to first dose was documented. One foot and ankle consultant and one trained fellow gave the popliteal blocks. The block was administered in the lateral position at 0.8 mAmp stimulus to detect the nerve. Group A and B data was compared statistically.

Results: The average pain scores in group A were reported to be 1.2 at 30min, 1.23 at 6, 2.1 at 12 and 3 at 24 hours. In group B it was 1.2 at 30min, 7.2, 8.1 and 4 at 6, 12 and 24 hours. There was a statistical significant difference in the pain scores at 6 and 12 hours. There was no statistical significant difference in the pain scores at 30 min and 24 hours.

Conclusion: Popliteal block gives effective pain relief in ankle and hindfoot surgery. We believe that it may reduce anaesthetic and analgesic drug requirement as well.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 70 - 70
1 Apr 2019
Chimento G Patterson M Thomas L Bland K Nossaman B Vitter J
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Introduction

Regional anesthesia is commonly utilized to minimize postoperative pain, improve function, and allow earlier rehabilitation following Total Knee Arthroplasty (TKA). The adductor canal block (ACB) provides effective analgesia of the anterior knee. However, patients will often experience posterior pain not covered by the ACB requiring supplemental opioid medications. A technique involving infiltration of local anesthetic between the popliteal artery and capsule of knee (IPACK) targets the terminal branches of the sciatic nerve, providing an alternative for controlling posterior knee pain following TKA.

Materials and Methods

IRB approval was obtained, a power analysis was performed, and all patients gave informed consent. Eligible patients were those scheduled for an elective unilateral, primary TKA, who were ≥ 18 years old, English speaking, American Society of Anesthesiologists physical status (ASA PS) classification I-III. Exclusion criteria included contraindication to regional anesthesia or peripheral nerve blocks, allergy to local anesthetics, allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), chronic renal insufficiency with GFR < 60, chronic pain not related to the operative joint, chronic (> 3 month) opioid use, pre-existing peripheral neuropathy involving the operative limb, and body mass index (BMI) ≥ 40 kg/m2.

Patients were randomized into one of two treatment arms: Continuous ACB with IPACK (IPACK Group) block or Continuous ACB with sham subcutaneous saline injection (No IPACK Group). IPACK Group received single injection of 20 mL 0.25% Ropivacaine. Postoperatively, all patients received a standardized multimodal analgesic regimen. The study followed a double-blinded format. Only the anesthesiologist performing the block was aware of randomization status.

Following surgery, a blinded medical assessor recorded cumulative opioid consumption, average and worst pain scores, and gait distance.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 346 - 346
1 May 2006
Dabby D Patisch H Blumberg N Cohen I Jakim I
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The proper management of radial head fractures is difficult and controversial. The radial head is intra-articular, part of the forearm ring and participates in both flexion and extension as well as in pronosupination. Our main goal in treating those fractures is anatomic restoration of the joint surface and early mobilization. Excision of the radial head, a well described procedure, may result in elbow instability and proximal migration of the radius. In this work we tried to avoid those complications by either conserving the head (ORIF) or by using a Radial head prosthesis.

Material and Methods: 20 Patients were enrolled into the study between 2003–2004. They were divided into 2 groups. 10 patients had ORIF and in patients the Corin Radial head prosthesis was used. Post-op all patients started immediate CPM. All patients were followed-up for 12–28 months (average 18.6). XR were taken each time and clinical examination was done, ROM was noted as well as muscle strength. Elbow stability was tested only on the 2nd month post op. Patient satisfaction was noted based of their function ability, and the amount of pain. Pain was rated on a scale of 1–10.

Results: Both groups passed the surgery uneventfully. No neurovascular damage nor infection were noted. In clinical examination the elbow was found to be stable in both groups. Decreased ROM in compare with the other elbow was found in both groups, but was more prominent in he ORIF group. One patient in the ORIF group in which biodegradable rod was used developed moderate synovitis that passed without intervention after 9 weeks. XR reveled that one patient in the ORIF group developed Heterotopic ossification, no dislocation or subluxation of the prosthesis was seen. Regarding to pain, in the ORIF group the patients rated their pain as milder in compare to those in the prosthetic group.

Conclusions: Both methods result in stable elbow but the ORIF group showed tendency to experience less pains and the prosthesis group showed tendency to better ROM.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 72 - 72
1 Mar 2010
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Introduction: We sought to determine the 1 year patient based outcomes and return to activities for patients with tibia fractures in a randomized trial of reamed and unreamed nail insertion.

Methods: 1226 patients with 830 closed and 392 open tibial shaft fractures were enrolled in a randomized trial comparing reamed with unreamed tibial nail insertion and completed one year follow-up. The average age was 39±16 and 74% were male. Patient based outcomes were determined using the validated SF-36 PCS, the SMFA, and a published return to activity questionnaire. Statistical analysis was performed as a stratified analysis comparing the groups with p < 0.05 designated as significant.

Results: There was no difference in any outcome parameter for any time frame between the reamed and unreamed groups. The 1 year SF36 PCS (a 100 point scale with a mean of 50 in the general population, higher better) was 42.9±11 for the reamed group and 43.5±11 for unreamed group as compared with 52.5±9 for the reamed group and 53.1±9 for the unreamed group pre-injury. The 1 year SMFA (100 point scale, higher is worse) was 18±17 for the reamed group and 17.5±17 for the unreamed group as compared with 7.9±13 for the reamed group and 7.7±13 unreamed group pre-injury.

Conclusion: In patients with tibial shaft fractures treated with intramedullary nails, patient based outcomes are not related to reamed or unreamed insertion. Patients do not return to their preinjury status based on validated outcomes assessments or return to activity by one year after injury.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 477 - 477
1 Sep 2009
Wardlaw D Bastian L Van Meirhaeghe J Ranstam J Cummings SR Eastell R Shabe P Tillman JB Boonen S
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Background: Balloon kyphoplasty is a minimally invasive treatment for acute vertebral fractures that aims to reduce and correct vertebral deformity by inserting expandable balloon tamps and then stabilize the body by filling it with bone cement. The effect of balloon kyphoplasty on quality of life has not been tested in a randomized trial.

Methods: Patients with up to 3 non-traumatic acute vertebral compression fractures were enrolled within 3 months of diagnosis and randomly assigned to receive either balloon kyphoplasty (N=149) or usual nonsurgical care (N=151). Measurements of quality of life, back pain and function, and days of disability and bed rest and spine radiographs were assessed through 12 months of follow-up.

Results: Compared with those assigned to nonsurgical care, participants assigned to balloon kyphoplasty had 5.2 points (95% CI, 2.9 to 7.4; p< 0.0001) greater improvement in the physical component of the SF-36 quality of life questionnaire at one month and 1.5 points (95% CI, − 0.8 to 3.8; p=0.2) at twelve months. Those in the balloon kyphoplasty group also had greater improvement in quality of life by the EuroQol questionnaire at one (0.18 points; 95% CI, 0.08 to 0.28; p=0.0003) and twelve months (0.12 points; 95% CI, 0.01 to 0.22; p=0.025) and improved disability by the Roland-Morris scale at one month (4.0 points; 95% CI, 2.6 to 5.5; p< 0.0001) and twelve months (2.6 points; 95% CI, 1.0 to 4.1; p=0.0012). Balloon kyphoplasty patients had less back pain on a 0 to 10-point numeric rating scale at seven days (2.2 points; 95% CI, 1.6 to 2.8; p< 0.0001) and twelve months (0.9 points; 95% CI, 0.3 to 1.5; p=0.0034) and reported fewer days of limited activity at one month (2.9 days per 2 weeks; 95% CI, 1.3 to 4.6; p=0.0004) and twelve months (1.6; 95% CI, − 0.1 to 3.3; p=0.068). Fewer patients assigned to balloon kyphoplasty took pain medications or used walking aids during follow-up. There was no significant difference in the number of patients with adverse events or serious adverse events in the kyphoplasty and nonsurgical groups. New radiographically detected vertebral fractures occurred in 41.8% of subjects in the balloon kyphoplasty and 37.8% in the nonsurgical group (4% difference; 95% CI − 7.5 to 15.6; p=0.5) and were not statistically different.

Conclusion: Compared to nonsurgical treatment, balloon kyphoplasty safely improved quality of life and reduced back pain, disability and the use of pain medications and walking aids. Significant improvements in multiple measurements of quality of life, pain and disability continue for at least 1 year. Balloon kyphoplasty did not increase adverse events including the risk of vertebral fractures (Clinicaltrials.gov number, NCT00211211).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 479 - 479
1 Sep 2012
Nikolopoulos D Sergides N Safos G Karagiannis A Papagiannopoulos G
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BACKGROUND

As life expectancy in the population rises, osteoporotic fractures are seen most frequently in the vertebral column. Percutaneous kyphoplasty is increasingly used for pain reduction and stabilization in these patients, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain.

OBJECTIVE

To clarify whether kyphoplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 387 - 387
1 Jul 2010
Dahl J Rydinge J Rohrl S Snorrason F Nordsletten L
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Introduction: C-stem is a triple taper polished femoral stem. The rationale for this design is to achieve an evenly distributed proximal loading of the cement mantle. This design is thought to enhance stability of the stem inside the mantle and lead to bone remodelling medially. There is to our knowledge no randomized trial comparing this stem to a well documented stem. We chose to compare it to the best documented stem in the Norwegian arthroplasty register, the Charnley monoblock.

Methods: 70 patients scheduled for total hip replacement were randomized to either C-stem or Charnley monoblock. All received a 22 mm stainless steel head, OGGEE cup and Palacos Cement with Gentamycin. We used a transgluteal approach in all cases. Harris and Oxford hip scores were measured preoperatively and after two years. Standard X-rays were taken postoperatively and after two years. Radiostereometry (RSA) was done postoperatively and after 3,6,12 and 24 months.

Results: There was no significant difference in Harris or Oxford hip scores after two years.

RSA after two years: (table deleted)

Discussion: Polished tapered stems are designed to sink inside the mantle. Our results confirm this theory for the C-stem. The subsidence is comparable to other collarless tapered stems with good long-term survival. For all other migrations/rotations the C-stem is as stable as the Charnley monoblock. This predicts good long-term results for this stem.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 147 - 147
1 Mar 2008
Harato K Bourne R Marr J Overhauser J
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Purpose: The purpose of this study was to compare the outcomes of cruciate retaining (CR) and cruciate sacrificing (CS) total knee arthroplasty (TKA) in a multi-center randomized clinical trial with greater than 5 year follow-up.

Methods: One hundred and eighty five patients (189 knees) participated in a double-blinded randomized clinical trial. 96 cruciate retaining and 93 cruciate sacrificing total knee arthroplasties (Genesis II, Smith & Nephew, Memphis, TN) were performed between 1997 and 2000. All surgical procedures were performed by twelve surgeons at twelve medical centers. The average follow-up was 5.8 (5.0–7.3) years. Clinical outcomes (Knee Society Clinical Rating, WOMAC, SF-12, Radiographic Findings) were evaluated preoperatively and at the latest follow-up. Postoperative complications were also examined.

Results: There were no significant differences when comparing cruciate retaining knees to cruciate sacrificing knees in patient demographics and preoperative clinical evaluation. At the latest follow-up, clinical outcomes (CR versus CS) were as follows: Knee Society Clinical Rating (163±26 versus 165±29), knee flexion (114±11& #12539;versus 118±10& #12539; p< 0.05), WOMAC (12±7 versus 8±6, p< 0.05), and SF-12 (mental: 52±9 versus 58±4, physical: 41±11 versus 42±10). Radiographic outcomes showed there were no differences in radiolucent lines or loosening, and postoperative complication rate was also not significantly different.

Conclusions: In this randomized clinical trial, both posterior cruciate preserving (CR) and sacrificing (CS) total knee replacements offer excellent clinical outcomes at five or more years follow-up, with the cruciate sacrificing implant studied demonstrating small, but significant improvements in both range of motion, WOMAC, and disease specific outcomes.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 41 - 41
1 Mar 2010
Becker SWJ Wardlaw D Bastian L Van Meirhaeghe J Ranstam J Cummings S Boonen S
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Purpose: Balloon kyphoplasty (BKP) is a minimally invasive treatment for acute vertebral compression fractures (VCF) that aims both to correct associated vertebral deformity (reduce) and stabilize the fracture by injecting bone cement. We performed the first multicenter randomized trial to assess the effect of BKP.

Method: Patients with 1–3 non-traumatic vertebral compression fractures diagnosed within 3 months were randomly assigned to receive either BKP (N=149) or usual nonsurgical care (NSC) (N=151). Measurements of quality of life, back pain and function, days of disability and bed rest were assessed at baseline, 1, 3, 6 and 12 months.

Results: The primary outcome measure, the difference between groups in change from baseline scores in the physical component summary of the SF-36 questionnaire, improved 3.5 points (95% CI, 1.6 to 5.4; p=0.0004) more in the BKP group when averaged across 12 months of follow-up. Compared with the NSC group, those assigned to BKP also had greater improvement in quality of life and back function throughout 12 months of follow-up as measured by the EuroQol and Roland-Morris scales; a difference of 0.14 points (95% CI, 0.05 to 0.23; p=0.0023) more and 3.2 points (95% CI, 1.7 to 3.8; p< 0.0001) and reported fewer days of limited activity in the previous 2 weeks due to back pain (2.5 fewer days; 95% CI, 1.2 to 3.8; p=0.0001). New radiographically detected vertebral fractures occurred in 41.8% of subjects in the kyphoplasty and 37.8% in the nonsurgical group (4% difference; 95% CI −7.5 to 15.6; p=0.5).

Conclusion: Compared to nonsurgical treatment, balloon kyphoplasty improved multiple measurements of quality of life, back pain and disability that last at least one year after the procedure. No difference is seen between groups in radiographically detected VCF’s (Clinicaltrials.gov number, NCT00211211).


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_II | Pages 149 - 149
1 Feb 2004
Cheng E Bailey B Gillingham K
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Introduction: Osteoneocrosis of the femoral head (ONFH) is difficult to treat as collapse frequently occurs after core decompression. This may be due to the failure to provide structural support during revascularization and healing after core decompression. Cement (PMMA) packing for giant cell tumors of bone has been shown to provide adequate support of the subchondral bone. This study was undertaken to determine whether or not the addition of PMMA packing provides any benefit to the outcome of core decompression for ONFH. Secondary objectives were to assess various factors for prognostic significance.

Materials and Methods: A prospective, randomized trial of core decompression ± cement (PMMA) packing for ARCO stage I or II ONFH was conducted. Outcome measures were: radiographic (XR) progression, conversion to hip arthroplasty (THA), WOMAC, SF 36, and Harris Hip scores (HHS). Survivorship analysis using Kaplan-Meier estimates was performed.

Results: The time to XR progression at 3 years for the core vs. core + PMMA cohorts was 42 ± 11 mo vs. 45 ± 12 mo, p=0.68, respectively. The time to THA at 3 yrs for the core vs. core± PMMA groups was 42 ± 11 mo vs. 67 ± 12 mo, p=0.17, respectively. Comparing pre vs.1 year postoperative WOMAC scores, for the core + PMMA group, there were statistically significant improvements in pain (p=0.082), stiffness (p=0.03), physical function (p= 0.05) and total score (p=0.03) whereas for the core decompression group, there was no significant difference noted among the same domains (p=0.06, 0.25, 0.74, 0.88) respectively. The SF 36 role physical domain score was higher for the core + PMMA group at 1 year (p=0.07) and 15 mos (p=0.09) but was no different at 3 yrs (p=85). For the physical function and bodily physical domains, there was no difference at any time point. The factors of smoking (y/n) p=0.003, location (central/ medial/lateral) p=0.03, per cent femoral head involvement (< 15, 15–30, > 30%) p=0.05, age (< 40, ≥40 yrs), and necrotic arc (< 40, ≥40) p=0.005, were significant predictors for XR progression on univariate analysis but upon Cox multivariate regression, only age (p=0.09), smoking (p=0.07), and necrotic arc (p=0.04) remained independently, statistically significant.

Discussion: The addition of PMMA packing to core decompression for pre-collapse ONFH (ARCO I/II) does not improve the outcome of treatment as measured by XR progression and conversion to THA. There is a benefit to PMMA packing for pain relief at 12–15 mos. as measured by the mean WOMAC, HHS and SF 36/role physical scores but this benefit ceases at 3 years after treatment. Age ≥40 years, smoking, and necrotic arc ≥40 are all predictive of eventual progression of disease on XR.


Winner of ISFR Best Paper Award

Introduction: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. We assessed the impact of reamed versus unreamed intramedullary nailing on re-operation rates.

Methods: The Study to Prospectively Evaluate Reamed Intamedullary Nails in Tibial Fractures (SPRINT) was a multi-center, randomized trial including 29 clinical sites. 1339 patients with tibial shaft fractures were randomized to either reamed or unreamed intramedullary nail insertion. Re-operations before 6 months were not permitted unless there was critical bone loss. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures.

Results: Of 1339 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender, and fracture types. The overall event rate was 17.8% (13.7% closed, 27%, open fractures). In 826 patients with closed fractures, patients with a reamed nail had a relative risk reduction of 33% (95%CI: 4–53%, P=0.03). This treatment effect was largely driven by differential autodynamization rates (rel risk: 0.42, p=0.01). Among 400 patients with open fractures, there was a trend towards an increased risk of an event (rel. risk=1.27, p=0.16) for those who received a reamed nail.

Conclusions: Our overall incidence of revision surgery was lower than reported in previous studies. Optimizing peri-operative care and avoiding premature re-operation may substantially decrease the need for re-operation in tibial fracture patients.


Purpose: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. The SPRINT primary objective aimed to assess the impact of reamed versus unreamed intramedullary nailing on rates of re-operation in patients with tibial shaft fractures.

Method: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Fractures (SPRINT) was a multi-centre, randomized trial including 29 clinical sites. SPRINT enrolled 1319 patients with open or closed tibial shaft fractures. Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were not permitted unless there was critical bone loss. Patients received a statically locked intramedullary nail with either reamed or unreamed insertion. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. Our sample size calculations required 1200 patients followed for 1 year.

Results: Of 1319 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender and closed and open fracture types (I-IIIB). The overall event rate was 17.8% (13.7% closed, 26.5%, open fractures). A significant subgroup interaction effect in patients with open versus closed fractures (p=0.01) mandated a separate analysis for each subgroup. In 826 patients with closed fractures, patients with a reamed nail had a relative risk reduction of 33% (95%CI: 4–53%, P=0.03). This treatment effect was largely driven by differential autodynamization rates (rel. risk: 0.42, p=0.01). Among 400 patients with open fractures, there was a trend towards an increased risk of an event (rel. risk=1.27, p=0.16) for those who received a reamed nail.

Conclusion: Our overall incidence of revision surgery was lower than reported in previous studies. Possible reasons for the overall lower event rates in SPRINT are:

standardization of surgical and post-surgical care resulted in superior care among the SPRINT centres and surgeons and

proscription of surgery until after 6 months. Optimizing peri-operative care and avoiding premature re-operation may substantially decrease the need for re-operation in tibial fracture patients.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 56 - 56
1 Mar 2008
Harley B Beaupre L Scharfenberger A Jomha N Weber D
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We compared the radiographs, clinical outcomes, and complications of two techniques used for treatment of unstable distal radius fractures in young adults. Fifty patients were randomized to percutaneous pinning or augmented external fixation. At one year follow-up, the external fixator did not improve the parameters of radial length, radial angulation or volar tilt. Reduction of intra-articular steps was slightly improved. No differences in DASH scores or functional outcomes were observed, but more complications were noted with the fixator. While articular restoration can be slightly improved with use of the external fixator, a higher incidence of complications and patient dissatisfaction was noted.

Two common techniques for treatment of unstable distal radius fractures in young adults include percutaneous pinning combined with plaster cast, and application of an external fixator, frequently with adjunctive pinning.

The objective of this study was to:

1. To compare the short and mid-term radiographic and clinical outcomes of these two common fixation techniques.

2. To compare the complications of the two techniques.

Fifty patients (< 65 yrs) with unstable fractures of the distal radius were recruited. Patients were randomized pre-operatively to percutaneous pinning or external fixation. All surgery was performed by one of three surgeons. Patients were followed for one year with radiographs and an independent clinical exam including DASH questionnaires.

86% of fractures were AO classification C2 or C3, with an equal distribution of all types in both treatment groups. Use of an external fixator did not improve the parameters of radial length, radial angulation or volar tilt. However, reduction of intra-articular steps was slightly improved with its’ use. No differences in mean DASH scores, total ROM or grip strength were observed. More pin complications were noted with the fixator, and all three patients diagnosed with RSD received external fixation.

While external fixation represents a popular first line treatment for unstable distal radius fractures, this study suggests that similar gross radiographic and clinical results can be obtained with percutaneous pinning. While articular restoration can be slightly improved with use of the external fixator in highly comminuted fractures, this must be balanced by a higher incidence of complications and patient dissatisfaction.

Funding: Stryker-Howmedica-Osteonics


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 156 - 156
1 May 2011
Renken F Schulz A Renken S Unger A Paech A
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Introduction: Less invasive surgical technique in THA is expected to minimize soft tissue damage and expedite rehabilitation. Due to this, it is now in widespread use in elective THA. The large geriatric patient population suffering a fractured neck of femur thereby would also benefit of this technique. Aim of this study was to evaluate if this technique is feasible in the non-elective setting of geriatric patients and if there are benefits regarding clinical and social outcome.

Patients and Methods: Study setup is a prospective randomized trial with a positive Ethical Committee vote. Included were patients under legal care of a third party. Inclusion criteria were the indication for bipolar hip arthroplasty including grade ASA 4; exclusion criteria included neoplastic disease and rheumatoid arthritis. Setting is a large university hospital. After biometrical evaluation, each arm was set as 30 patients. Primary end point was the modified Barthel index. 48 patients were female. Mean age for female patients was 85.5, for male 82.9 years. There was no detectable difference in the groups regarding age, sex and BMI. As a less invasive approach, the well described „Direct Anterior Approach-DAA”(modified Smith-Petersen approach) was chosen. In the other arm the Watson-Jones approach was used. The ABG II stem with a bipolar UHR head (Stryker) were used in both groups. To minimize the learning curve, 10 cadaver- and 15 clinical procedures were performed with the DAA approach before the study. The pre- and postoperative regimen was identical in both arms. The modified Barthel index and other clinical parameter were determined preoperatively and at 4 postoperative intervals up to 40 days.

Results: There were no statistical differences between both groups for intra- and postoperative complications. The mean theatre time was 4.8 minutes longer for the DAA group, in the first 10 patients this difference was measured with 16 minutes. The Barthel Index was only statistically different at 40 days, at this time the DAA patients had reached their preoperative mobility level whilst the conventional approach patients (with a pre-operative level of 42.5) were measured with 25 points. The hemoglobin levels on day 5 and 16 were significantly different with a higher Hb for the DAA group. All other parameters showed no significant difference.

Conclusion: The DAA approach has a clear learning curve. Once this has passed, the theatre time is only slightly longer. There is a detectable benefit regarding early rehabilitation and a slight but significantly reduced blood loss.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 485 - 486
1 Apr 2004
Davis A O’Sullivan B Bell R Turcotte R Catton C Wunder J Chabot P Hammond A Benk V Isler M Freeman C Goddard K Bezjak A Kandel R Sadura A Day A James K Tu D Pater J Zee B
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Introduction Morbidity associated with wound complications may translate into disability and quality-of-life disadvantages for patients treated with radiotherapy (RT) for soft tissue sarcoma (STS) of the extremities. Functional outcome and health status of extremity STS patients randomized in a phase III trial comparing pre-operative versus post-operative RT is described.

Methods One hundred and ninety patients with extremity STS were randomized after stratification by tumor size dichotomized at 10 cm. Function and quality of life were measured by the Musculoskeletal Tumor Society Rating Scale (MSTS), the Toronto Extremity Salvage Score (TESS), and the Short Form-36 (SF-36) at randomization, six weeks, and three, six, 12, and 24 months after surgery. One hundred and eighty-five patients had function data.

Results Patients treated with post-operative RT had better function with higher MSTS (25.8 v 21.3, P < .01), TESS (69.8 v 60.6, P =.01), and SF-36 bodily pain (67.7 v 58.5, P =.03) scores at six weeks after surgery. There were no differences at later time points. Scores on the physical function, role-physical, and general health sub-scales of the SF-36 were significantly lower than Canadian normative data at all time points. After treatment arm was controlled for, MSTS change scores were predicted by a lower-extremity tumor, a large resection specimen, and motor nerve sacrifice; TESS change scores were predicted by lower-extremity tumor and prior incomplete excision. When wound complication was included in the model, patients with complications had lower MSTS and TESS scores in the first two years after treatment.

Conclusions The timing of RT has minimal impact on the function of STS patients in the first year after surgery. Tumor characteristics and wound complications have a detrimental effect on patient function.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 47 - 47
1 Mar 2008
Pirani S McKee M
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In five teaching hospitals, seventy-two patients with seventy-three bicondylar tibial plateau fractures were prospectively randomized by envelope to treatment either by AO methods (group A) or ring fixator methods (group B). Outcome measures included clinical and radiographic parameters, & HSS knee scores.

Results: Re-intervention was necessary within six months in ten group A & seven Group B patients. Forty-three procedures were performed (thirty-three Group A-ten Group B) I& D 12- 3: STSG 3-0: Quadricepsplasty 1-0; Manipulation 2–4; Muscle flap 2–0; Above knee amputation 1–0; Revision ORIF 5–1; Revision Rings 0–1; Bone graft 2–1; Bead pouch 3-0; Synovectomy 1-0; Sequestrectomy 1-0.

More patients had more septic and wound complications resulting in more need for re-intervention following ORIF.

Conclusion. For bi-condylar tibial plateau fractures (OTA 41.C) six-month HSS scores are significantly higher after treatment with Ring Fixator methods. Reintervention rates for deep sepsis/wound problems are higher with AO methods. Wound and infection complications occurring after AO treatment are more severe and require multiple procedures for control.

We have conducted a prospective randomized trial to determine the outcomes of treatment by

Open reduction and internal fixation or

Closed reduction and ring fixation for the treatment of bi-condylar tibial plateau fractures (OTA 41.C)

We report our early findings on re-intervention rates for complications.

In five teaching hospitals, seventy-two patients with seventy-three bi-condylar tibial plateau fractures were prospectively randomized by envelope to treatment either by AO methods (group A) or ring fixator methods (group B). Outcome measures included clinical and radiographic parameters, & HSS knee scores. Randomization gave the following demographics

Re-intervention was necessary within six months in ten group A & seven Group B patients. Forty-three procedures were performed (thirty-three Group A-ten Group B) I& D 12- 3: STSG 3-0: Quadricepsplasty 1-0; Manipulation 2-4; Muscle flap 2-0; Above knee amputation 1-0; Revision ORIF 5-1; Revision Rings 0-1; Bone graft 2-1; Bead pouch 3-0; Synovectomy 1-0; Sequestrectomy 1-0.

More patients had more septic and wound complications resulting in more need for re-intervention following ORIF.

For bi-condylar tibial plateau fractures (OTA 41.C) six-month HSS scores are significantly higher after treatment with Ring Fixator methods. Reintervention rates for deep sepsis/wound problems are higher with AO methods. Wound and infection complications occurring after AO treatment are more severe and require multiple procedures for control.

Please contact author for pictures and/or diagrams.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 470 - 470
1 Nov 2011
Lewis P Moore C Olsen M Schemitsch E Waddell J
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Oxidized Zirconium (Oxinium, Smith & Nephew, Inc., Memphis, TN) is a relatively new material that features an oxidized ceramic surface chemically bonded to a tough metallic substrate. This material has demonstrated the reduced polyethylene wear characteristics of a ceramic, without the increased risk of implant fracture. The purpose of the current investigation was to assess clinical outcomes following primary total hip arthroplasty with Oxinium versus Cobalt Chrome femoral heads.

One hundred uncemented primary total hip arthroplasty procedures were prospectively performed in 100 patients. There were 52 males and 48 females with mean age at the time of surgery of 51 years (SD 11, range, 19–76). Using a process of sealed envelope randomization, patients were divided into 2 groups. Each group contained fifty patients. Those in group 1 received an Oxinium femoral head (OX), while those in group 2 a cobalt-chrome femoral head (CC).

The current study reports clinical outcome measures for both the OX and CC groups at a minimum follow-up of 2 years postoperatively. At the time of latest follow-up, stem survival for both groups was 98%. There was a significant improvement in all clinical outcome scores between preoperative and 2 year postoperative time periods for both bearing groups (p< 0.003). There were no significant differences between bearing groups for any of the clinical outcome scores at final follow-up (p> 0.159). Mean Harris Hip Scores at 2 years postoperatively were 92 and 92.5 for OX and CC, respectively (range; 65–100 OX, 60–100 CC). For SF-12, both the Physical Component Summary Scale (PCS) and the Mental Component Summary Scale (MCS) are reported. Mean PCS scores at final follow-up were 45.2 and 49.21 for OX and CC (range; 27.1–56.7 OX, 26.3–61.8 CC). Mean MCS scores were 53.8 and 52.57 for OX and CC (range; 39.2–65.5 OX, 34.3–64 CC). Mean final WOMAC scores are reported as 84.9 and 87 for OX and CC, respectively.

The current data suggest that total hip arthroplasty utilizing Oxinium femoral heads is safe and effective. Additional follow-up of the current cohort will be performed in order to fully assess mid-to long-term clinical outcomes.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 39 - 39
1 Mar 2010
Howard AW
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Purpose: Sports and leisure is the second leading cause of severe childhood injury after road traffic. Severe fractures from school playgrounds are common and preventable. Falling height and impact absorbing surface determine risk. We compared two loose fill surfaces (sand versus engineered wood fibre) to determine arm fracture risk.

Method: Twenty eight elementary schools in the same urban public school board were scheduled for playground replacement and consented to random assignment of either sand (14) or wood fibre (14) beneath the new playground. Two and a half school years of injury data were collected. Arm fractures were defined a priori as the primary outcome of interest.

Results: 267,864 student-months of followup data were collected; 84824 with sand and 183040 with wood fibre. Schools complied (surface installed as randomized) for 73% of the total followup time. Fracture rates were 4.1 per 100,000 student months on sand playgrounds and 13.0 per 100,000 student months on wood fibre playgrounds (p=0.112, analysis adjusted for clustering). Time for play, counts of children playing, weather, and completeness of injury reporting did not differ between groups.

Conclusion: Children at schools with sand surfaces had a lower arm fracture rate related to playground equipment falls. Using sand surfaces instead of engineered wood fibre surfaces is a simple and effective way of reducing arm fractures from playgrounds. This is the only randomized trial we are aware of regarding playground surfacing, and the finding is novel.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 162 - 162
1 Mar 2009
Gollwitzer H Diehl P von Korff A Schauwecker J Gerdesmeyer L
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Context: Published data on extracorporeal shock wave therapy (ESWT) for chronic plantar fasciitis provide controversial evidence about the clinical relevance and effectiveness. Treatment parameters have significant influence on outcome and optimal treatment protocols have to be determined.

Objective: To assess the effect size and safety of ESWT compared to placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device and an optimized protocol.

Design, Setting, and Participants: Prospective, double-blind, randomized, placebo-controlled trial conducted among 40 patients. Interventions: ESWT (0.25 mJ/mm2) or placebo without anesthesia. Both groups received 3 treatments of 2000 shock wave impulses, each session 1 week apart. Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as changes of single VAS scores (morning pain, pain at daily activities and pain with force-meter application), success rates and changes in Roles and Maudsley score.

Results: ESWT resulted in a 73.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, being 32.7% superior to placebo. Effect size reached clinical relevance (Mann-Whitney effect size (MW) = 0.6737; 0.6400 being the benchmark for medium-sized, relevant superiority, p = 0.0302 single-sided). With regard to the percentage changes of the single VAS scores and the Roles and Maudsley score, the effect size denoted relevant superiority of the ESWT as well (all MWs ≥ 0.6400). No relevant adverse events occurred.

Conclusion: The results of the present study advocate ESWT for refractory painful heel syndrome demonstrating clinically relevant effect sizes. Specific treatment protocols with proven effectiveness ought to be used in the clinical setting.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1196 - 1200
1 Nov 2023
Parker MJ Chatterjee R Onsa M Cawley S Gurusamy K

Aims

The aim of this study was to report the three-year follow-up for a series of 400 patients with a displaced intracapsular fracture of the hip, who were randomized to be treated with either a cemented polished tapered hemiarthroplasty or an uncemented hydroxyapatite-coated hemiarthroplasty.

Methods

The mean age of the patients was 85 years (58 to 102) and 273 (68%) were female. Follow-up was undertaken by a nurse who was blinded to the hemiarthroplasty that was used, at intervals for up to three years from surgery. The short-term follow-up of these patients at a mean of one year has previously been reported.


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

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

Methods

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


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 95 - 95
1 Mar 2010
Lewis P Al-Belooshi A Olsen M Schemitsh E Waddell J
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Total hip replacement in the young active patient remains one of the major challenges in orthopaedics today. The use of ultra high molecular weight (UHMW) polyethylene acetabular liners is known to cause polyethylene wear related osteolysis, the major limiting factor in its use in the younger active patient. Modern alumina ceramic articulations have been developed in order to reduce wear and avoid polyethylene debris. This prospective randomized long-term study aims to compare the outcome between an alumina ceramic-on-ceramic (CC) articulation with a ceramic on UHMW polyethylene articulation (CP). In the younger active patient, is one option superior to the other with regard to patient satisfaction, osteolysis and implant longevity?

56 hips in 55 patients with mean age 42.2 (range 19–56) each received uncemented components (Wright Medical) and a 28mm alumina head with acetabular liner selected via sealed envelope randomization following anesthetic induction. Subsequent regular clinical and radiologic follow up measured patient outcome scores and noted any radiological changes.

26 CP hips and 30 CC hips were evaluated. One failure required revision in each group. Mean St Michael’s outcome score for each group with up to 10 years follow-up (median 8 years, range 1–10) was 22.8 and 22.9 respectively (p=0.057). Radiographs with a minimum 5 years post-operative follow-up were analyzed in 42 hips (23 CC and 19 CP). Radiolucency of all 3 acetabular zones was identified in one of the CP hips. There was no evidence of osteolysis or loosening identified in the remaining hips. The mean time of wear measurement for the CC group was 8.3 years (SD 1.3, Range 4.8–10.1 years) and for the CP group was 8.1 years (SD 0.9, Range 6.1–9.2 years)(p=0.471). Wear was identified in all but one of the CP replacements but only 12 of 23 CC articulations. The mean wear for the CC group was 0.14 mm (SD 0.16, Range 0–0.48 mm) and for the CP group was 0.89 mm (SD 0.6, Range 0–2.43 mm)(p< 0.001). Extrapolating the annual wear rate from these figures, the respective wear is 0.02mm for the CC group compared to 0.11mm per year for the CP group.

To our knowledge this is the first long term randomized trial comparing in vivo ceramic-on-ceramic with ceramic-on-conventional polyethylene hip articulations. Other than significantly greater wear in the polyethylene group there was no significant difference in long-term outcome scores between the two groups with up to 10 years of follow-up. The use of a ceramic-on-ceramic bearing is a safe and durable option in the young patient avoiding the concerns of active metal ions and osteolytic polyethylene debris. These patients remain under review.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 12 - 12
10 May 2024
Sevic A Patel C Tomlinson M
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Introduction

Comparative studies examining Fixed-Bearing (FB) and Mobile-Bearing (MB) Total Ankle Replacement (TAR) designs have demonstrated similar results and successful long-term outcomes for both. To date there has been no study directly comparing FB and MB designs of the same prosthesis. We present the first prospective randomised trial comparing patient satisfaction, functional outcomes and radiographic results of the Salto Talaris Fixed-Bearing and the Salto Mobile-Bearing Total Ankle Replacement in the treatment of end-stage ankle arthritis.

Methods

A total of 108 adult patients with end-stage ankle arthritis were enrolled in the study between November 2014 and October 2021 with similar demographic comparison. Prospective patient-reported outcomes and standardised weightbearing ankle radiographs were performed preoperatively, at 6 weeks, 6 months and 12 months post-operatively, followed by yearly intervals. All surgeries were performed by a single non-design orthopaedic foot and ankle specialist with experience in over 200 Salto and Salto Talaris TAR prior to the study. Radiographs were examined independently by two clinicians. Complete patient data and radiographs were available for 103 patients with an average follow up of 2 years.


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

Introduction

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

Methods

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


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

Introduction

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

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

Method

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


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

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

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

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


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

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

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

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