Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy (BASTION)

May 4, 2026 updated by: Uppsala University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale:

Basal joint arthritis of the thumb (trapeziometacarpal osteoarthritis) is a common condition causing pain and reduced hand function. While trapeziectomy with ligament reconstruction/capsuloplasty has long been a gold standard, total joint arthroplasty, such as the TOUCH prosthesis, has gained popularity. However, there is a lack of high-quality prospective randomized controlled trials (RCTs) comparing these methods regarding long-term functional outcomes, complication rates, and cost-effectiveness. This study aims to compare the clinical and health-economic outcomes of total joint arthroplasty with TOUCH prosthesis versus trapeziectomy with capsuloplasty.

Study Design and Randomization:

This is a prospective, randomized controlled trial. Following informed consent obtained by the attending surgeon, participants are randomized to either:

  1. Total joint arthroplasty using the TOUCH prosthesis.
  2. Trapeziectomy with capsuloplasty. Randomization is performed in close proximity to the day of surgery. Due to the nature of the interventions, participants are informed of the surgical method postoperatively.

Procedures and Follow-up

  • Surgical Intervention: Both procedures are performed according to standardized institutional protocols.
  • Postoperative Care (Trapeziectomy): The thumb is immobilized in a cast for 3 weeks, followed by a standardized rehabilitation program led by occupational and physical therapists.
  • Postoperative Care (total joint arthroplasty): A stable soft dressing is applied for 3 weeks, followed by the same rehabilitation protocol.
  • Follow-up Schedule: Participants are evaluated at 3 weeks, 6 weeks, 12 weeks, 12 months, 24 months, 5 years, and 10 years postoperatively.
  • Imaging: Radiographic evaluations are performed for the prosthesis group at 6 weeks, 12 months, 24 months, 5 years, and 10 years to monitor for prosthesis loosening or "z-deformity" (MCP joint hyperextension) compared to the trapeziectomy group.

Data Management and Quality Assurance:

Data is collected and managed using REDCap (Research Electronic Data Capture) to ensure data integrity and validation. Physical informed consent forms are stored securely at the Department of Hand Surgery. Source data verification is performed by comparing registry data against electronic medical records and paper-based Case Report Forms (CRFs).

Sample Size and Power Calculation:

The primary outcome is Jamar grip strength at 12 months. Based on a Minimal Clinically Important Difference (MCID) of 6.5 kg and a standard deviation (SD) of 8.5 kg (derived from existing literature and pilot data), a power calculation (90% power, alpha 0.05, two-sided t-test) determined a requirement of 37 patients per group. To account for a 10% dropout rate, the total cohort size is set at 84 patients (42 per arm).

Health Economic Analysis:

A comprehensive health economic evaluation will be conducted to compare the total costs of both methods. This analysis includes:

  • Direct Costs: Implant costs, anesthesia, surgical time, and healthcare utilization (number of visits).
  • Indirect Costs: Duration of sick leave and time to return to work.
  • Secondary Metrics: Analgesic consumption (paracetamol and opioids), patient-reported quality of life (EQ-5D), and "pain-free days" based on NRS (Numerical Rating Scale) assessments.

The objective is to determine if the higher initial cost of the TOUCH prosthesis is offset by faster recovery, reduced sick leave, and improved long-term productivity.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elias Gardell, MD, attending hand surgeon
  • Phone Number: +46 (0) 186171544
  • Email: elias.gardell@uu.se

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Department of Handsurgery, Uppsala University Hospital
        • Contact:
          • Elias Gardell, MD, attending hand surgeon
          • Phone Number: +46(0) 186171544
          • Email: elias.gardell@uu.se
        • Contact:
          • Sara Edsfeldt, MD, PhD, senior attending
          • Phone Number: +46 (0) 186119031
          • Email: sara.edsfeldt@uu.se
        • Principal Investigator:
          • Sara Edsfeldt, MD, PhD, senior attending
      • Örebro, Sweden
        • Orebro University Hospital
        • Contact:
        • Principal Investigator:
          • Eva Lundqvist, MD, PhD, senior attending

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous surgery to thumb base or STT-joint
  • Ongoing chronic pain condition
  • Dementia or cognitive impairment
  • Trapezium height <7 mm on plain radiograph
  • Active smoker
  • Osteoarthritis grade 4 (Eaton-Littler)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • TOUCH Dual-Mobility Prosthesis
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: Measured at 12 months postoperatively
Hand grip strength (JAMAR dynamometer) at 12 months post operatively
Measured at 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key-pinch grip strength
Time Frame: Measured at 6 weeks, 12 weeks, and 12 months postoperatively
Key-pinch strength measured by pinch-gauge in kilograms
Measured at 6 weeks, 12 weeks, and 12 months postoperatively
Pinch grip strength
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
3-finger pinch strength measured by pinch gauge in kilograms
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Postoperative Pain Intensity on a Numeric Rating Scale (NRS)
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Pain measured with the Numerical Rating Scale (NRS) at rest and load, where 0 is "no pain" and 10 is "worst imaginable pain"
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Range of movement
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Range of movement of thumb measured by physiotherapist. Extension, flexion, volar abduction, radial abduction. In degrees.
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Metacarpophalangeal (MCP)-joint hyperextension
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Radiographic MCP-joint hyperextension (Z-deformity)
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Complications
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Complications, such as trigger thumb, de Quervain's, reoperation, and infection, reported within 12 months of surgery.
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Use of analgesics
Time Frame: Measured at 12 months postoperatively
Total usage of analgesic during the post operative period.
Measured at 12 months postoperatively
Duration of sick leave
Time Frame: Measured at 12 months postoperatively
Total duration of sick leave.
Measured at 12 months postoperatively
Patient-reported outcomes EQ-5D
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire EQ-5D
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcomes QUICK-DASH
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire QUICK-DASH
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcomes PRWHE
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire PRWHE
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcomes Michigan hand questionnaire (MHQ)
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire Michigan hand questionnaire (MHQ)
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcomes Michigan hand questionnaire HQ-8
Time Frame: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire HQ-8
Measured at 6 weeks, 12 weeks and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Örebro County Council
Uppsala County Council, Sweden

Investigators

  • Study Director: Nils Hailer, MD, PhD. Professor, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
  • Principal Investigator: Sara Edsfeldt, MD, PhD, senior attending, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
  • Study Chair: Sara Edsfeldt, MD, PhD, senior attending, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

March 1, 2038

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr2026-00547-01
  • 2026-00547-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 6 months and ending 5 years after publication. Requests should be directed to Central contact person. To gain access, data requestors will need to sign a data access agreement and provide proof of approval from the Swedish Ethical Review Authority.

IPD Sharing Time Frame

Beginning 6 months and ending 5 years after publication

IPD Sharing Access Criteria

Access will be granted to qualified academic researchers who provide a methodologically sound scientific proposal. The request must be consistent with the informed consent provided by the participants. Access requires a formal Data Sharing Agreement (DSA) and a valid ethical approval from the Swedish Ethical Review Authority (Etikprövningsmyndigheten). The requesting party must also demonstrate that they have the necessary infrastructure to handle sensitive data according to GDPR

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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