Comparing Trapeziectomy Surgery Versus Sham Surgery for Treating Thumb Base Osteoarthritis in Adults Over 45

What this Trial Is About

Researchers are evaluating the effectiveness of trapeziectomy surgery compared to sham surgery in patients with persistent painful osteoarthritis at the base of the thumb CMC1. This multi-center, randomized, placebo-controlled trial aims to understand how these treatments affect pain and hand function, with the main focus on patient-reported outcomes six months after treatment. The study also monitors longer-term effects up to five years. Participants are assigned to one of three groups the trapeziectomy group, which undergoes surgical removal of the trapezoideum bone the sham surgery group, which receives only a skin incision without actual bone removal and a non-randomized observational group receiving trapeziectomy without blinding. Both surgical procedures are performed under medical supervision, and the study compares outcomes between these groups. During the trial, participants will report their wrist and hand function and pain levels using the Patient Reported Wrist and Hand Evaluation PRWHE at multiple time points 3 months, 6 months, 1 year, 2 years, and 5 years. Other assessments include grip and pinch strength, global improvement, patient-accepted symptom states, and quality of life measured by the EUROQOL EQ-5D-5L. The study is designed to carefully monitor patient experiences and outcomes over an extended period to better understand the impact of trapeziectomy on thumb osteoarthritis.

Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb