Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy

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.

Conditions

• Thumb Osteoarthritis
• Thumb Carpometacarpal Joint Osteoarthritis
• Carpometacarpal (CMC) Joint Arthritis
• Basal Thumb Osteoartrithis

Interventions

DEVICE

Implantation of trapeziometacarpal prosthesis

Surgical implantation of the TOUCH trapeziometacarpal total joint prosthesis (Kerimedical). The prosthesis consists of an uncemented stainless steel stem inserted into the first metacarpal and a dual cup mobility system with a polyethylene ball articulating against a metal cup fixed in the trapezium. The stem is available in straight or 15-degree angled neck configurations. Postoperative management consists of a stable soft dressing for 3 weeks to allow early controlled mobilization, followed by a standardized hand therapy rehabilitation protocol.

PROCEDURE

Trapeziectomy with Capsuloplasty

Surgical excision of the trapezium bone (trapeziectomy) followed by capsuloplasty using a distally based dorsal capsular flap, without tendon interposition. The capsular flap is sutured to stabilize the base of the first metacarpal. No implant or tendon graft is used. Postoperatively, a cast immobilizing the thumb in functional position is applied for 3 weeks, followed by a standardized hand therapy rehabilitation protocol.

Sponsors & Collaborators

• Uppsala County Council, Sweden

  collaborator OTHER_GOV

• Örebro County Council

  collaborator OTHER_GOV

• Uppsala University

  lead OTHER

Principal Investigators

• Nils Hailer, MD, PhD. Professor · Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden

• Sara Edsfeldt, MD, PhD, senior attending · Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden

• Sara Edsfeldt, MD, PhD, senior attending · Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2030-05-31

Completion

2038-03-31

Countries

• Sweden

Study Locations