Design and execution of clinical trials in orthopaedic surgery

Mundi, Raman; Chaudhry, Harman; Mundi, Simran; Godin, Katelyn; Bhandari, Mohit

doi:10.1302/2046-3758.35.2000280

Cited by 36 publications

(16 citation statements)

References 52 publications

(102 reference statements)

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“…Emails were personalized to each trialist and to each research question, with the protocol synopsis corresponding to the specific clinical question provided. We focused on orthopaedics because the number of clinical trials performed in this field is low [ 29 – 31 ] as compared with other specialties, so cooperation of trialists and data sharing are crucial to provide high-level evidence regarding the efficacy of interventions.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of individual patient data meta-analyses in orthopaedic surgery

Villain

Dechartres

Boyer

et al. 2015

BMC Med

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BackgroundThe number of individual patient data meta-analyses published is very low especially in surgical domains. Our aim was to assess the feasibility of individual patient data (IPD) meta-analyses in orthopaedic surgery by determining whether trialists agree to send IPD for eligible trials.MethodsWe performed a literature search to identify relevant research questions in orthopaedic surgery. For each question, we developed a protocol synopsis for an IPD meta-analysis and identified all related randomized controlled trials (RCTs) with results published since 2000. Corresponding authors of these RCTs were sent personalized emails that presented a project for an IPD meta-analysis corresponding to one of the research questions, with a link to the protocol synopsis, and asking for IPD from their RCT. We guaranteed patient confidentiality and secure data storage, and offered co-authorship and coverage of costs related to extraction.ResultsWe identified 38 research questions and 273 RCTs related to these questions. We could contact 217 of the 273 corresponding authors (79 %; 56 had unavailable or non-functional email addresses) and received 68/273 responses (25 %): 21 authors refused to share IPD, 10 stated that our request was under consideration and 37 agreed to send IPD. Four corresponding authors required authorship and three others asked for financial support to send the IPD. Overall, we could obtain IPD for 5,110 of 33,602 eligible patients (15 %). Among the 38 research questions, only one IPD meta-analysis could be potentially initiated because we could receive IPD for more than 50 % of participants.ConclusionThe present study illustrates the difficulties in initiating IPD meta-analyses in orthopaedic surgery. Significant efforts must be made to improve data sharing.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-015-0376-6) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Feasibility of individual patient data meta-analyses in orthopaedic surgery

Villain

Dechartres

Boyer

et al. 2015

BMC Med

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“…Only a limited amount of funding went to surgical research in spite of the relatively large contribution of surgery to effective treatment [ 38 ]. These practical obstacles might have caused a substantial decrease in the quantity of RCTs in surgical research compared to other fields of medicine [ 4 , 39 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical research on postoperative trauma care: has the position of observational studies changed?

Smeeing

Houwert²,

Kruyt

et al. 2016

Eur J Trauma Emerg Surg

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ObjectiveThe postoperative care regimes of ankle fractures are studied for over 30 years and recommendations have shifted only slightly in the last decades. However, study methodology might have evolved. The aim of this study was to evaluate the changes in time in the design, quality and outcome measures of studies investigating the postoperative care of ankle fractures.MethodsThe MEDLINE and EMBASE database were searched for both RCTs and cohort studies. The original studies were divided into decades of publication over the last 30 years. The methodological quality of the studies was assessed using the ‘traditional’ risk of bias assessment tool provided by The Cochrane Collaboration and the ‘newer’ MINORS criteria.ResultsThe percentage of RCTs on this subject declined from 67 to 38 % in the last decades. According to the Cochrane tool, the reported quality of RCTs has improved in the last three decades whereas the reported quality of observational studies has remained unchanged. However, when quality was evaluated with the MINORS criteria, equal improvement was observed for both RCTs and observational studies. In the 80s, 67 % of all studies used the range of motion as the primary outcome measure, which decreased to 45 % in the 90s. In the 00s, none of the studies used the range of motion as the primary outcome.ConclusionFor postoperative care of ankle fractures, results of this study showed a relative decrease in the published number of RCTs. The overall quality of the published articles did not decline. In addition, a gradual shift from physician measured to patient-reported outcome variables was observed. However, it should be borne in mind that the findings are based on a small sample (n = 25).

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“…One challenge is that there is often a heavy emphasis on subjective outcome measures (e.g. daily activities and pain scales) that are vulnerable to placebo-effects and do not consistently correlate with physiological outcomes (e.g., cartilage thickness and disc height) (Mundi et al, 2014). A second issue is the difficulty of blinding surgeons and patients in a surgical intervention, such as with autologous BM aspiration, which is critical for determining whether isolated cells can be effective in treating tissue injuries or degeneration.…”

Section: Progress and Concerns For Stem And Stromal Cell Therapymentioning

confidence: 99%

Engineering Stem and Stromal Cell Therapies for Musculoskeletal Tissue Repair

2018

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Stem cells and tissue-derived stromal cells stimulate the repair of degenerated and injured tissues, motivating a growing number of cell-based interventions in the musculoskeletal field. Recent investigations have indicated that these cells are critical for their trophic and immunomodulatory role in controlling endogenous cells. This Review presents recent clinical advances where stem cells and stromal cells have been used to stimulate musculoskeletal tissue repair, including delivery strategies to improve cell viability and retention. Emerging bioengineering strategies are highlighted, particularly toward the development of biomaterials for capturing aspects of the native tissue environment, altering the healing niche, and recruiting endogenous cells.

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Design and execution of clinical trials in orthopaedic surgery

Cited by 36 publications

References 52 publications

Feasibility of individual patient data meta-analyses in orthopaedic surgery

Feasibility of individual patient data meta-analyses in orthopaedic surgery

Clinical research on postoperative trauma care: has the position of observational studies changed?

Engineering Stem and Stromal Cell Therapies for Musculoskeletal Tissue Repair

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