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Design and execution of clinical trials in orthopaedic surgery.

ABSTRACT: 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.

SUBMITTER: Mundi R

PROVIDER: S-EPMC4097861 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Design and execution of clinical trials in orthopaedic surgery.

Mundi R R Chaudhry H H Mundi S S Godin K K Bhandari M M

Bone & joint research 20140501 5

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 discussi ...[more]

PMID: 24869465

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Project description:BackgroundThe primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials.MethodsPilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT).ResultsThe initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question.ConclusionsBased on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Project description:Background: venous thromboembolism (VTE) is one of the most common complications after major orthopaedic surgery. Recent studies have suggested that aspirin may also be effective in preventing VTE, but it is still controversial whether it can be routinely used. Objectives: To compare the efficacy and safety of aspirin against oral anticoagulants in the prevention of VTE following total hip arthroplasty (THA), total knee arthroplasty (TKA) or hip fracture surgery (HFS). Methods: Relevant publications have been obtained using electronic search databases such as PubMed, Embase, Web of Science, Cochrane Library, and Clinical Trials. gov. from inception to 20 July 2023. Only RCTs evaluating the efficacy and safety of aspirin compared with oral anticoagulants undergoing major orthopaedic surgery were included in the meta-analysis. The primary outcome reported was any VTE event (including deep vein thrombosis (DVT) and pulmonary embolism (PE)). Secondary outcomes included mortality, major bleeding (including gastrointestinal bleed, cerebrovascular hemorrhage, or any bleeding requiring a return to the theater), minor bleeding (ecchymosis, epistaxis, hematuria), and wound complications. The risk of bias for all included studies was assessed according to the Cochrane Collaboration's tool. Results: After screening 974 studies, 12 randomized clinical trials (RCTs) were included, involving 5,088 participants, including 2,540 participants in aspirin, 2,205 participants in rivaroxaban, and 323 participants in warfarin. Aspirin was found to be less effective than oral anticoagulants in thromboprophylaxis after major orthopedic surgery (RR = 1.206, 95% CI 1.053-1.383). After subgroup analysis according to the type of oral anticoagulant, the results showed that aspirin was similar to rivaroxaban and inferior to warfarin. Considering that the studies in the warfarin group were all conducted before 2000, our results need to be further confirmed. In addition, the aspirin group had a higher risk of VTE than the control group in other subgroups, including a follow-up time of ≤3 months, type of procedure as TKA, high-dose aspirin (≥650 mg qd), and no combined use of mechanical prophylaxis. In terms of safety events, aspirin did not show significant differences in major bleeding (RR = 0.952, 95% CI 0.499-1.815), all-cause mortality (RR = 1.208, 95% CI 0.459-3.177), and wound-related events (RR = 0.618, 95% CI 0.333-1.145) compared with oral anticoagulants, and aspirin was associated with a reduction in the risk of minor bleeding (RR = 0.685, 95% CI 0.552-0.850) events and total bleeding (RR = 0.726, 95% CI 0.590-0.892). Conclusion: Aspirin reduces bleeding risk after major orthopedic surgery compared with oral anticoagulants, but may sacrifice VTE prevention to some extent. Updated evidence is needed to analyze the thromboprophylaxis effects of aspirin in patients undergoing major orthopedic surgery. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=463481, identifier CRD42023463481.

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Design and execution of clinical trials in orthopaedic surgery.

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Design and execution of clinical trials in orthopaedic surgery.

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