No phaseRecruitingAge-related condition
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy (BASTION)
BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy
- Sponsor
- Uppsala University (Academic or other)
- Enrolment
- 84 planned
- Conditions
- Thumb Osteoarthritis; Thumb Carpometacarpal Joint Osteoarthritis; Carpometacarpal (CMC) Joint Arthritis; Basal Thumb Osteoartrithis
- Interventions
- Implantation of trapeziometacarpal prosthesis; Trapeziectomy with Capsuloplasty
- Ages
- adults, older adults
- Registry
- NCT07569549
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Hand grip strength
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered