Improving Evidence in Hand and Wrist Surgery: A Systematic Assessment of Randomized Controlled Trials Quality and Impact

Abstract

Background:

Randomized controlled trials (RCTs) are the gold standard for generating clinical evidence; however, many in hand and wrist surgery fall short in delivering clinically relevant insights. We systematically evaluated RCTs published over the last 25 years to assess their clinical usefulness and utility.

Methods:

We assessed the usefulness of 88 RCTs published between 2000 and 2025 involving surgical, perioperative, or nonoperative interventions in hand and wrist surgery. Studies were identified through Medline and Embase. Each trial was evaluated using a validated 13-item framework incorporating 8 usefulness criteria and 5 transparency indicators. Screening and data extraction were performed in masked duplicate fashion. The protocol was pre-registered on the Open Science Framework.

Results:

Of the 88 included RCTs, 99% addressed a clinically important question, but only 13% employed a pragmatic study design. Patient-centered outcomes were included in 52% of trials, and validated patient-reported outcome measures were used in just 39%. While 47% of trials were pre-registered, only 5% shared raw data. Overall, just 11% of studies achieved a usefulness score of 75% or greater on our 13-item framework. Trials most frequently originated from Europe (38%) and were published in hand surgery journals (42%).

Conclusions:

Many RCTs in hand and wrist surgery lack pragmatic design, patient-centered outcomes, and transparency. Improving these areas can increase real-world relevance and guide practicing surgeons’ clinical decision-making.