Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis (T3)

Thumb carpometacarpal osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited.

This is a single-centre, blinded randomised controlled trial at Sahlgrenska University Hospital, Gothenburg, Sweden. Adults aged 18-69 years with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment will be randomised 1:1 to trapeziometacarpal prosthetic arthroplasty or trapeziectomy. The primary outcome is day-by-day pain (registration on a numeric rating scale NRS, 0-10). Secondary outcomes include day-by-day analgesic consumption for 90 days, orthosis use after cast removal, patient-reported function (HQ-8, QuickDASH, and Nelson score) at 30, 45, 60, 75 and 90 days, assessor-measured range of motion and strength at 45 and 90 days, and long-term clinical follow-up at 6 months and 1, 2, 5 and 10 years. Cone beam computed tomography will be obtained in the arthroplasty group at 1 week postoperatively as reference and at 6 months and 1, 2, 5 and 10 years to assess implant position, migration and loosening. The target sample size is 64 participants (32 per group), providing 95% power to detect a 1-point between-group difference on the pain scale. Analyses will follow the intention-to-treat principle.

Study Overview

• Status: Not yet recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Procedure: trapeziometacarpal arthroplasty; Procedure: Trapeziectomy

Detailed Description

Aim and objectives The primary aim is to compare early postoperative pain trajectories after CMC-1 arthroplasty versus trapeziectomy for symptomatic thumb carpometacarpal osteoarthritis, using day-by-day patient-reported pain measurements during the first 90 postoperative days.

Secondary aims are to compare:

(i) Daily analgesic consumption during the first 90 postoperative days (ii) Orthosis use after cast removal (iii) Patient-reported hand/upper limb function using HQ-8, QuickDASH and Nelson score (iv) Blinded clinical measures of thumb range of motion, grip strength and pinch strength (v) Long-term clinical outcomes up to 10 years. Additionally, in the arthroplasty group, a long-term aim is to evaluate migration and radiological signs of implant loosening using cone beam computed tomography (CBCT). Similarly, in the trapeziectomy group, CBCT will be used to monitor and quantify metacarpal 1 proximal migration.

This protocol has been prepared in accordance with SPIRIT 2025 guidance [18], and includes a PRO EDI participant characteristics (Table 1).

Trial design This is a single-centre, assessor-blinded randomised controlled trial (RCT) with 1:1 allocation to prosthetic CMC-1 arthroplasty or trapeziectomy.

Study setting The study will be conducted at the Hand Surgery Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden. All operations will be performed by surgeons experienced in both techniques at least level 3 according to Giddins-Tang classification [19] and have at minimum overcome the previously described learning curve thresholds [20,21].

Eligibility criteria

Inclusion criteria:

• Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
• Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-4.
• For Eaton grade 2, age ≥50 years.
• Age 18-69 years.
• Provision of written informed consent.

Exclusion criteria:

• Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
• Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
• Post-traumatic thumb carpometacarpal osteoarthritis.
• Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
• Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
• Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
• Ongoing systemic corticosteroid treatment.
• Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
• Cognitive impairment preventing reliable participation.
• Ongoing, or suspected ongoing, alcohol or drug misuse.
• Insufficient Swedish language proficiency to complete the questionnaires.

Participant identification, recruitment and consent Potential participants will be identified among patients referred for surgical evaluation of symptomatic thumb carpometacarpal osteoarthritis at the study site. Eligible patients will receive verbal and written information about the study. Written informed consent will be obtained before any study-specific data collection.

At baseline, participants will complete the HQ-8, QuickDASH and Nelson score questionnaires. Baseline demographic characteristics will be recorded in line with the PRO

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joakim Stromberg, Md,PhD; Phone Number: +46768341327; Email: joakim.stromberg@vgregion.se
• Study Contact Backup: Name: Victoria Wängberg, MD; Phone Number: +46739804631; Email: victoria.wangberg@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
• Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-3.
• For Eaton grade 2, age ≥50 years.
• Age 18-69 years.
• Provision of written informed consent.

Exclusion Criteria:

• Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
• Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
• Post-traumatic thumb carpometacarpal osteoarthritis.
• Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
• Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
• Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
• Ongoing systemic corticosteroid treatment.
• Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
• Cognitive impairment preventing reliable participation.
• Ongoing, or suspected ongoing, alcohol or drug misuse.
• Insufficient Swedish language proficiency to complete the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trapeziometacarpal joint arthroplasty; Implantation of the Touch® CMC-1 prosthesis	Procedure: trapeziometacarpal arthroplasty; Participants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free.
Active Comparator: Trapeziectomy; Surgical excision of the trapezium	Procedure: trapeziometacarpal arthroplasty; Participants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free.; Procedure: Trapeziectomy; Participants allocated to trapeziectomy will undergo surgical excision of the trapezium without tendon interposition according to routine practice at the study site. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Patient-reported pain at the thumb base, measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain).	daily for three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesics used	Daily registration of analgesic consumption	daily for three months
Use of Orthosis	• Orthosis use and perceived importance recorded weekly after cast removal	Daily for three months
Patient-reported thumb symptoms	measured with Nelson score (a disease specific questionnaire)	at 30, 45, 60, 75 and 90 postoperative days
Patient-reported upper extremity function	measured with QuickDASH questionnaire	at 30, 45, 60, 75 and 90 postoperative days
Patient-reported hand function	measured with HQ-8 questionnaire	at 30, 45, 60, 75 and 90 postoperative days
Range of motion	Objective thumb range of motion (radial and volar abduction) measured by a blinded assessor	at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Strength	Grip strength and pinch strength measured by a blinded assessor	at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Migration of prosthesis on cone beam computed tomography	• Long-term radiological assessment with CBCT in the arthroplasty group to assess implant position, migration and loosening and to assess metacarpal 1 migration in the trapeziectomy group	at 6 months and 1, 2, 5 and 10 years (with a 1-week reference scan).

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Joakim Stromberg, MD, PhD, Sahlgrenska University Hospital, University of Gothenburg

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: The T3 Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No