We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (β < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number. Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results

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

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

We performed a systematic review and meta-analysis to compare the efficacy of intermittent mechanical compression combined with pharmacological thromboprophylaxis, against either mechanical compression or pharmacological prophylaxis in preventing deep-vein thrombosis (DVT) and pulmonary embolism in patients undergoing hip or knee replacement. A total of six randomised controlled trials, evaluating a total of 1399 patients, were identified. In knee arthroplasty, the rate of DVT was reduced from 18.7% with anticoagulation alone to 3.7% with combined modalities (risk ratio (RR) 0.27, p = 0.03; number needed to treat: seven). There was moderate, albeit non-significant, heterogeneity (I. 2. = 42%). In hip replacement, there was a non-significant reduction in DVT from 8.7% with mechanical compression alone to 7.2% with additional pharmacological prophylaxis (RR 0.84) and a significant reduction in DVT from 9.7% with anticoagulation alone to 0.9% with additional mechanical compression (RR 0.17, p < 0.001; number needed to treat: 12), with no heterogeneity (I. 2. = 0%). The included studies had insufficient power to demonstrate an effect on pulmonary embolism. We conclude that the addition of intermittent mechanical leg compression augments the efficacy of anticoagulation in preventing DVT in patients undergoing both knee and hip replacement. Further research on the role of combined modalities in thromboprophylaxis in joint replacement and in other high-risk situations, such as fracture of the hip, is warranted

We conducted a randomised, controlled trial to determine whether changing gloves at specified intervals can reduce the incidence of glove perforation and contamination in total hip arthroplasty. A total of 50 patients were included in the study. In the study group (25 patients), gloves were changed at 20-minute intervals or prior to cementation. In the control group (25 patients), gloves were changed prior to cementation. In addition, gloves were changed in both groups whenever there was a visible puncture. Only outer gloves were investigated. Contamination was tested by impression of gloved fingers on blood agar and culture plates were subsequently incubated at 37°C for 48 hours. The number of colonies and types of organisms were recorded. Glove perforation was assessed using the water test. The incidence of perforation and contamination was significantly lower in the study group compared with the control group. Changing gloves at regular intervals is an effective way to decrease the incidence of glove perforation and bacterial contamination during total hip arthroplasty

The use of robots in orthopaedic surgery is an emerging field that is gaining momentum. It has the potential for significant improvements in surgical planning, accuracy of component implantation and patient safety. Advocates of robot-assisted systems describe better patient outcomes through improved pre-operative planning and enhanced execution of surgery. However, costs, limited availability, a lack of evidence regarding the efficiency and safety of such systems and an absence of long-term high-impact studies have restricted the widespread implementation of these systems. We have reviewed the literature on the efficacy, safety and current understanding of the use of robotics in orthopaedics.

Cite this article: Bone Joint J 2015; 97-B:292–9.

The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.

We evaluated the quality of guidelines on thromboprophylaxis in orthopaedic surgery by examining how they adhere to validated methodological standards in their development. A structured review was performed for guidelines that were published between January 2005 and April 2013 in medical journals or on the Internet. A pre-defined computerised search was used in MEDLINE, Scopus and Google to identify the guidelines. The AGREE II assessment tool was used to evaluate the quality of the guidelines in the study.

Seven international and national guidelines were identified. The overall methodological quality of the individual guidelines was good. ‘Scope and Purpose’ (median score 98% interquartile range (IQR)) 86% to 98%) and ‘Clarity of Presentation’ (median score 90%, IQR 90% to 95%) were the two domains that received the highest scores. ‘Applicability’ (median score 68%, IQR 45% to 75%) and ‘Editorial Independence’ (median score 71%, IQR 68% to 75%) had the lowest scores.

These findings reveal that although the overall methodological quality of guidelines on thromboprophylaxis in orthopaedic surgery is good, domains within their development, such as ‘Applicability’ and ‘Editorial Independence’, need to be improved. Application of the AGREE II instrument by the authors of guidelines may improve the quality of future guidelines and provide increased focus on aspects of methodology used in their development that are not robust.

Cite this article: Bone Joint J 2014;96-B:19–23.