Raman Mundi

Cartilage Restoration of the Knee A Systematic Review and Meta-Analysis of Level 1 Studies

Background: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). Purpose: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Study Design: Systematic review and meta-analysis of randomized controlled trials. Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. Results: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm2 were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, –0.19 to 1.13]; P = .16) or pain (standardized mean difference, –0.13 [95% CI, –0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. Conclusion: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.

Complication Reporting in Orthopaedic Trials

BACKGROUND The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials. METHODS Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories. RESULTS One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications. CONCLUSIONS The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

How good is the orthopaedic literature

Randomized trials constitute approximately 3% of the orthopaedic literature Concerns regarding quality of the orthopaedic literature stem from a widespread notion that the overall quality of the surgical literature is in need of improvement. Limitations in surgical research arises primarily from two pervasive issues: 1) A reliance on low levels of evidence to advance surgical knowledge, and 2) Poor reporting quality among the high level surgical evidence that is available. The scarcity of randomized trials may be largely attributable to several unique challenges which make them difficult to conduct. We present characteristics of the orthopaedic literature and address the challenges of conducting randomized trials in surgery.

Surgical preferences of patients at risk of hip fractures: hemiarthroplasty versus total hip arthroplasty.

BackgroundThe optimal treatment of displaced femoral neck fractures in patients over 60 years is controversial. While much research has focused on the impact of total hip arthroplasty (THA) and hemiarthroplasty (HA) on surgical outcomes, little is known about patient preferences for either alternative. The purpose of this study was to elicit surgical preferences of patients at risk of sustaining hip fracture using a novel decision board.MethodsWe developed a decision board for the surgical management of displaced femoral neck fractures presenting risks and outcomes of HA and THA. The decision board was presented to 81 elderly patients at risk for developing femoral neck fractures identified from an osteoporosis clinic. The participants were faced with the scenario of sustaining a displaced femoral neck fracture and were asked to state their treatment option preference and rationale for operative procedure.ResultsEighty-five percent (85%) of participants were between the age of 60 and 80 years; 89% were female; 88% were Caucasian; and 49% had some post-secondary education. Ninety-three percent (93%; 95% confidence interval [CI], 87-99%) of participants chose THA as their preferred operative choice. Participants identified several factors important to their decision, including the perception of greater walking distance (63%), less residual pain (29%), less reoperative risk (28%) and lower mortality risk (20%) with THA. Participants who preferred HA (7%; 95% CI, 1-13%) did so for perceived less invasiveness (50%), lower dislocation risk (33%), lower infection risk (33%), and shorter operative time (17%).ConclusionThe overwhelming majority of patients preferred THA to HA for the treatment of a displaced femoral neck fracture when confronted with risks and outcomes of both procedures on a decision board.

Design and execution of clinical trials in orthopaedic surgery

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.

Open Tibial Fractures: Updated Guidelines for Management

Fractures of the tibial diaphysis represent the most common major long-bone fractures that currently confront practicing orthopaedic surgeons1,2. The overall incidence has been estimated to be seventeen to twenty-three fractures per 100,000 person-years, and it is young males in particular who carry the highest risk of sustaining these fractures, with a reported incidence of thirty-nine fractures per 100,000 person-years in males from ten to nineteen years of age3,4. Unfortunately, up to 24% (a total of …

Checklists to improve the quality of the orthopaedic literature

Several checklists have been developed in an effort to help journals and researchers improve the quality of reporting in research. The CONSORT statement and the CLEAR NPT evaluate randomized trials. The MOOSE and QUOROM checklists evaluate meta-analyses. The STROBE checklists assists readers in evaluating observational studies and the STARD checklist was developed for diagnostic test evaluation. The checklists presented here provide an invaluable source of guidance to authors, journal editors and readers who are seeking to prepare and evaluate reports. As evidence-based medicine continues to establish itself as the new paradigm by which medicine is practiced, the need for good reporting for all research designs must also become commonplace as opposed to the exception.

Operative blood loss, blood transfusion and 30-day mortality in older patients after major noncardiac surgery

Question: In elderly patients with variable preoperative anemia and volume of blood loss during major noncardiac surgery, does intraoperative blood transfusion reduce the risk of perioperative death? Design: Retrospective cohort study. Data source: National Surgical Quality Improvement Program database. Patients: Veterans aged 65 years or older with a documented preoperative hematocrit (HCT) value who underwent major noncardiac surgery between 1997 and 2004. Methods: Propensity score matching was used to adjust for differences between patients who received intraoperative blood transfusions (9.45) and those who did not. Main outcome: Association between intraoperative blood transfusion and 30-day postoperative mortality. Results: After propensity score matching, intraoperative blood transfusion was associated with mortality risk reduction in patients with preoperative HCT levels lower than 24% (odds ratio [OR] 0.60, 95% confidence interval [CI] 0.41–0.87) and in patients with HCT of 30% or greater who experienced substantial (500–999 mL) blood loss (OR 0.35, 95% CI 0.22–0.56 for HCT levels between 30% and 35.9%, and OR 0.78, 95% CI 0.62–0.97 for HCT levels of 36% or greater). When operative blood loss was less than 500 mL, transfusion was not associated with mortality reductions for patients with HCT levels of 24% or greater and conferred increased mortality risks in patients with preoperative HCT levels between 30% and 35.9% (OR 1.29, 95% CI 1.04–1.60). Conclusion: Intra-operative blood transfusion was associated with lower 30-day postoperative mortality among elderly patients undergoing major noncardiac surgery if there was substantial operative blood loss or low preoperative HCT levels (< 24%). Transfusion was associated with increased risk of death for those with preoperative HCT levels between 30% and 35.9% and less than 500 mL of blood loss.

Cochrane in CORR (®): Double-bundle Versus Single-bundle Reconstruction for Anterior Cruciate Ligament Rupture in Adults (Review).

A nterior cruciate ligament (ACL) injuries most commonly occur in young, active patients, with an annual incidence of more than 200,000 in the United States alone [8, 11, 13]. Approximately 65% of these patients undergo ACL reconstruction, but there is ongoing debate about the most appropriate techniques [6]. Earlier studies have explored the importance of tunnel placement, graft selection, graft fixation, and rehabilitation protocols, but recent attention has focused on the role of doublebundle reconstruction [2]. The native ACL consists of two discrete anteromedial and posterolateral bundles, which respectively account for translational and rotational stability [9, 10, 13]. Double-bundle ACL reconstruction involves reconstructing each of these bundles separately and is purported to more closely restore native knee anatomy and biomechanics. However, double-bundle ACL reconstructions are more technically demanding than conventional singlebundle techniques, they require greater operative time, and are more difficult to revise when they fail [10]. Multiple randomized controlled trials have been recently performed to evaluate whether double-bundle ACL reconstruction is superior to single-bundle

Variability in the Approach to Total Hip Arthroplasty in Patients With Displaced Femoral Neck Fractures

The aim of this study was to determine the degree of variability in implants, approaches, and associated complication rates in randomized controlled trials (RCTs) evaluating primary total hip arthroplasty (THA) as an intervention for displaced femoral neck fractures. We searched 2 medical databases for RCTs involving THA for femoral neck fractures published between June 2000 and June 2010. All analyses were descriptive. Nine RCTs met our inclusion criteria. We identified variability in both the surgical approach and choice of prosthesis. Trials generally standardized to head sizes of 28 mm or greater and cemented prostheses. Surgical experience varied across studies. Dislocation rates varied from 0% to 22%. There is considerable variability in RCTs evaluating THA for femoral neck fractures. Standardization toward optimal outcomes for femoral neck fractures is needed.