Overview of randomised controlled trials in orthopaedic research: search for significant findings
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The majority of recent orthopaedics randomised controlled trials (RCTs) have been non-inferiority trials with no significant clinical or statistical differences between treatment groups. The aim of this study was to evaluate randomised trials for significant findings in the orthopaedic literature based on the main elective procedures undertaken across different subspecialties.
We evaluated the following procedures: anterior cervical discectomy and fusion (ACDF), subacromial decompression (SAD), carpal tunnel decompression (CTD), total hip replacement (THR), anterior cruciate ligament reconstruction (ACLR), total knee replacement (TKR) and hallux valgus correction (HVC). Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2018, Issue 1), Ovid MEDLINE (1946 to 12 January 2018) and Embase (1980 to 12 January 2018). Trials that met our inclusion criteria were assessed using a binary outcome measure of whether they reported statistically significant findings.
We included 1078 RCTs across seven most commonly performed elective procedures. Of those, only 16% (172/1078) reported significant findings [ACDF 26/77 (33.8%); SAD 2/22 (9%); CTD 11/72 (15.3%); THR 52/281 (18.5%); ACLR 21/239 (8.8%); TKR 55/357 (15.4%); HVC 5/30 (16.7%)]. The number of RCTs per year of publication has increased dramatically particularly since early 2000s—with over 100 RCTs of those seven procedures published in 2017 alone.
This is the first study to undertake a comprehensive review of orthopaedic RCTs in elective practice. The number of RCTs in orthopaedic research is steadily increasing. However, only 16% of trials reports significant differences between interventions.
For trials comparing different surgical techniques, this evidence provides treating surgeons with the flexibility to utilise available resources and infrastructure to deliver patients care without compromising clinical outcomes. Further, for trials comparing different treatment modalities, this study helps to inform the shared decision-making process when counselling patients on the effectiveness of surgical interventions.
KeywordsOrthopaedic interventions Randomised controlled trials Non-inferiority trials
Compliance with ethical standards
Conflict of Interest
The author(s) declare that they have no competing interests.
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