Trapeziectomy Clinical Trials

Clinical trials related to Trapeziectomy Procedure

BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis. The main questions it aims to answer are: Does surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery? What is the long-term risk of complications for both methods? Which method is more cost-effective for the healthcare system? Researchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient. Participants will: Be randomized to undergo either an operation with total joint arthroplasty or a trapezectomy. Undergo an initial evaluation and a health economic cost analysis after one year. Attend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 40-80 years at inclusion

• CMC-joint osteoarthritis grade 1-3 (Eaton-Littler classification)

• Rest pain or pain reducing hand function with indication for surgery

• Insufficient relief from non-operative treatment for ≥3 months (orthosis, OTC analgesics, cortisone injection)

• Eligible for both prosthesis and trapezectomy per including surgeon

• Non-smoker or complete smoking cessation ≥6 weeks prior to surgery

Locations
Other Locations
Sweden
Örebro university hospital
NOT_YET_RECRUITING
Örebro
Department of Handsurgery, Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Eva Nordin, Clinical research nurse
eva.nordin@akademiska.se
+46(0) 186119630
Backup
Elias Gardell, MD, attending hand surgeon
elias.gardell@uu.se
+46 (0) 186171544
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2038-03
Participants
Target number of participants: 84
Treatments
Experimental: Arm 1 -Dual Mobility Prosthesis (TOUCH)
TOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Active_comparator: Arm 2 - Trapeziectomy and Capsular Reconstruction
Trapezectomy with capsuloplasty (n=42). Excision of trapezium with dorsal capsule flap capsuloplasty. Cast immobilization for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Related Therapeutic Areas
Sponsors
Leads: Uppsala University
Collaborators: Uppsala County Council, Sweden, Örebro County Council

This content was sourced from clinicaltrials.gov