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. Results. Statistical analysis assessed patient preference and the scores between the groups. Multi-variate analysis was performed to assess the factors that may be contributing to patient choice. Conclusion. Insights into patient preference and clinical outcomes associated with absorbable sutures and non-absorbable sutures in the setting of out-patient surgery are discussed

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161–8

Purpose. Elective ACLR is indicated for symptomatic instability of the knee. Despite being a common procedure, there are numerous surgical techniques, graft and fixation choices. Many have been directly compared in randomized trials and meta-analyses. The typical operation is arthroscopic-assisted, uses autograft tendon and screw fixation. Research in elective joint replacement surgery has demonstrated an inverse relationship between surgeon volume and revision and complication rates. How patient demographics, provider characteristics and graft/fixation choices influence ACLR revision rates has not been reported on a population level. We hypothesized that ACLR using tendon autograft and screw fixation performed by high volume surgeons will have the lowest rate of revision. In contrast, the risk of contralateral ACLR in the same cohort will be influenced only by patient factors. Method. All ACLR performed in Ontario from July 2003 to March 2008 on Ontario residents aged 14 to 60 were identified using physician billing, procedural and diagnostic codes from administrative databases. Data was accessed through the Institute for Clinical Evaluative Sciences. The main outcomes were revision and contralateral ACLR sought from inception until end of 2009. Patient factors (age, gender, income, co-morbidity), surgical choices (allograft or autograft tendon; screw, biodegradable or endobutton/staple fixation) and associated procedures (meniscal repair, collateral ligament surgery) were entered as covariates in a cox proportional hazards survivorship model. Mean cohort patient characteristics were chosen as reference groups. Surgical options and associated procedures were analyzed in a binary fashion (yes/no). Results. We identified 13,997 primary ACLR with a mean follow up of 3.2 years. The rate of revision ACLR was 1.8% (mean 1.9 years), and primary contralateral ACLR 2.0% (mean 2.0 years). In the cox model, younger age (14–19 yrs; HR 2.9, p<0.001), teaching hospital (HR 2.1, p<0.001) and the use of endobutton/staple fixation (HR 4.4, p=0.01) conferred a higher risk of revision. No effect of graft type or surgeon volume was found. Only younger age (14–19 yrs; HR 1.9, p=0.0005) and not any provider or surgical covariates conferred a significant risk of contralateral ACLR. Conclusion. Our results confirm that young age confers a higher risk of both revision and contralateral ACLR and these patients should be counseled accordingly pre-operatively. The use of endobutton or a staple for fixation was an independent risk for revision ACLR. This finding needs to be explored further in a direct fashion. Finally, we report that the mean time to revision ACLR was almost two years a fact that should impact future randomized controlled trial design and prompt re-evaluation of those already published which typically use only 1–2 years as the endpoint of data collection

Purpose. Previous studies have demonstrated pronounced reduction of sleep quality following major surgery, which may affect postoperative pain and early recovery. This prospective, randomized, controlled trial was designed to evaluate the effect of zolpidem on sleep quality in fast-track total knee arthroplasty (TKA). Methods. 180 patients who underwent primary TKA were enrolled in this study and randomized 1:1 to receive either zolpidem (Group A) or placebo (Group B) for 6 days. VAS pain scores (rest, ambulation, flexion, and night), range of motion (ROM), opioid analgesics use, postoperative nausea and vomiting (PONV) and other complication, sleep efficacy and patients VAS satisfaction were recorded postoperatively and at 1, 3, 5 after surgery. Sleep quality was measured using the polysomnography (PSG) and Epworth Sleepiness Scale. Results. Sleep efficiency was decreased on all three postoperative nights but returned to pre-admission levels on the fifth postoperative night in Group A. Compared to Group B, Group A showed better sleep quality in early period. It was found that patients taking zolpidem showed greater improvement in quality of life, better patient VAS satisfaction, lower pain VAS score, and less opioid analgesics use. Conclusion. In conclusion, sleep quality is impaired after total knee arthroplasty and zolpidem could improve postoperative sleep or pain and be beneficial to patients' post-TKA early recovery

Introduction. A recent meta-analysis published in the British Medical Journal suggested an increased risk of infection, but none of the studies were large enough to reach statistical significance. A prospective, randomised trial was designed at our institution to investigate the wound healing and complications related to surgery following fracture neck of femur in the elderly. Objectives. The primary aim was to compare the wound problems and infection following two different methods of skin closure: Subcuticular monocryl suture to metal clips for closure of skin. The secondary aim was to look at the duration of surgery after both types of closure. We received ethical approval for this study. We screened and recruited all eligible patients admitted with acute hip fracture undergoing hemi-arthroplasty or dynamic hip screw. We recruited 541 patients in the study over the period of 3.5 years at our institution. Methods. The study was approved by ethics committee. Inclusion Criteria: Age 18 years and above undergoing DHS/ Hemiarthroplasty and with full mental capacity. Exclusion criteria: Patients with no capacity or undergoing Total Hip Replacement or Nailing of femur. The randomisation was done by using the sealed envelopes. The wound review was done on post op days 2, 5, 7, 10 & 14. Results. 516 patients were included in the study. They were divided in to two groups, 252 Hemiarthroplasty and 264 DHS. Average age was 79.48 yrs. (range 31–100 yrs.), 357 Females and 159 males. Total 196 patients were followed up till day 14 and rest of the patients were discharged by the 10. th. post op day. Out of 516 patients, 278 patients had clips and 238 patients had sub cut monocryl suture for the wound closure. The average score was 1.20 (range 1–3) for the wounds (the group of 278 patients) closed with clips mainly due to bruising and oozing. The average score was 0.71(range 0–1) for the wounds (the 238 group of patients) closed with sub cut monocryl mainly due to bruising. We did not find any significant wound infection in either of these groups. Conclusion. The final review of our study showed that the wounds closed with sub cut monocryl had less wound healing issues (average score 0.71) as compared to the wounds closed with clips (average score 1.20)

Purpose. The purpose of this study was to compare and evaluate the cost-effectiveness of the MIS Anterolateral Approach to that of the MIS Posterolateral and MIS Direct Lateral Approach. Method. A prospective randomized control trial was designed and conducted to compare the MIS Anterolateral Approach to that of the MIS Posterolateral and MIS Direct Lateral Approach. Contemporary methods for economic evaluation were used to ascertain direct and indirect costs (in Canadian dollars) along with clinical effectiveness outcomes (SF6D and Pat5D utility measures). University and hospital ethics was obtained and patients were recruited and consented to participate in the RCT resulting in the assignment of 130 patients MIS hip arthroplasty procedures. Baseline patient demographics, comorbidity, quality of life, and utility were obtained for all patients. In-hospital costing data was obtained including operating room and patient room costs as well as medication, rehab and complications. Post-discharge costs were calculated from direct and indirect costs of medication, rehab, medical costs and complications until one year post-operatively. Clinical effectiveness measures were administered at intervals until one year post-operatively. Results. Patient groupings were similar pre-operatively with regards to demographic variables and quality of life measures (WOMAC, SF36, Pat5D). Post-operatively comparison of costs and complications were not different across the different surgical approaches (p>.05). Cost-effectiveness analyses (cost/QALY) were not statistically different (p>.05) when comparing the three MIS hip arthroplasty procedures. Conclusion. Primary total hip arthroplasty is a cost-effective surgical procedure and compares favorably with other health interventions. Our study is among the first to compare the cost-effectiveness of different MIS surgical approaches using contemporary methods of cost-effectiveness analyses. Our data suggests that the MIS Anterolateral approach is not superior to the MIS Posterolateral or MIS Direct Lateral approach with regards to cost-effectiveness of the intervention. Our economic evaluation was sensitive to early post-op complications including dislocation and re-operation. Surgeons should select an MIS approach based on criteria including technical preference, reliable implant placement, patient safety and complication minimization

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs.

Cite this article: Bone Joint Res 2014;3:169–74.