Open Versus Mini‐Incision Carpal Tunnel Release Using the ProMIS Kit: A Prospective Randomized Controlled Trial

Objective To compare short‐term clinical outcomes between mini‐incision carpal tunnel release (MCTR) using the ProMIS kit and conventional open carpal tunnel release (OCTR) in patients with carpal tunnel syndrome (CTS). Methods In this single‐center, prospective randomized trial, 90 adults with idiopathic CTS were allocated 1:1 to OCTR or MCTR. All procedures were performed by a single fellowship‐trained hand surgeon, and postoperative care was standardized. The primary endpoint was change in Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity and functional status scores at 2 months. Secondary outcomes were visual analog scale (VAS) pain, Patient‐Rated Wrist Evaluation (PRWE), Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores, grip strength, scar length, and procedure‐related complications. Analyses followed the intention‐to‐treat principle. Results Forty‐five participants were randomized to each group; most were middle‐aged women. Baseline clinical characteristics were comparable. At 2 weeks, the MCTR group reported lower VAS pain and better PRWE and QuickDASH scores than the OCTR group, indicating faster early functional recovery. By 1 and 2 months, between‐group differences in pain, BCTQ, PRWE, QuickDASH, and grip strength were small and not clinically important. No major complications, including iatrogenic nerve or tendon injury, wound infection, or reoperation, occurred in either group. Conclusion MCTR using the ProMIS kit offered modestly faster early recovery than conventional OCTR while providing similar short‐term symptom relief, functional improvement, and safety. MCTR appears to be a reasonable alternative to standard open release for CTS, but larger trials with longer follow‐up are warranted. Trial Registration: Thai Clinical Trials Registry: TCTR20220914002.