NCT05127005

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

A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.

Detailed description

A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.

Conditions

• Thumb Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Trapeziectomy	Surgical excision of trapezoideum
PROCEDURE	Sham	Skin incision only

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-12-01
• Completion: 2029-12-01
• First posted: 2021-11-19
• Last updated: 2022-01-21

Locations

4 sites across 1 country: Finland