TRACE - Thumb Base Replacement Arthroplasty for Osteoarthritis.

Not Applicable

Recruiting

• Conditions: Osteoarthritis of the CMC-1 Joint

• Registration Number: NCT07178223
• Lead Sponsor: Karolinska Institutet

Brief Summary

Osteoarthritis in the base of the thumb is one of the most common forms of hand arthritis. It usually appears in middle age, particularly in women, and can cause significant pain and loss of function. Early treatment often includes splints, painkillers, joint protection techniques, or steroid injections. If these measures are not enough, surgery is considered.

The current standard operation in Sweden is trapeziectomy-removing a small bone at the base of the thumb. This usually gives good pain relief at rest, but many patients continue to experience pain when loading the hand and reduced grip strength. Another surgical option is trapeziometacarpal limited excision (TLE), where only part of the bone is removed to keep the thumb slightly longer, which may improve strength. Both procedures are non-implant surgeries and are well established.

A newer alternative is total joint arthroplasty (TJA), where the joint is replaced with a prosthesis. Early studies suggest that this may allow for quicker recovery and possibly better strength compared to trapeziectomy. However, it is more expensive and carries higher risks, such as implant loosening or dislocation. So far, research has not proven that it offers better long-term results.

The TRACE study (A single arm trial of Thumb base Replacement Arthroplasty for osteoarthritis Compared to External controls) is designed to help answer this question. Instead of randomizing patients, this study will follow a group of people receiving thumb joint replacement at Södersjukhuset in Stockholm and compare them to an existing group of patients who already took part in a randomized trial of trapeziectomy and TLE. This design allows the researchers to study results more quickly and with fewer resources, while still ensuring meaningful comparisons.

The main research question of this study is whether joint replacement gives better pain relief when loading the thumb 10 years after surgery compared to traditional non-implant operations in patients with painful thumb base osteoarthritis. Secondary questions include whether joint replacement improves patient-reported outcomes, hand function, and strength, and whether it leads to more or fewer complications at 1, 3, and 5 years after surgery.

90 patients will be included in the replacement group, using a dual mobility prosthesis. Their outcomes will be compared with 90 patients from the earlier trial (45 trapeziectomy and 45 limited trapeziometacarpal joint resection - TLE). The study will track pain, daily hand function, strength, range of motion, and complications such as infection or the need for further surgery. Data will be collected regularly for up to 10 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-01
• Study First Submitted: 2025-08-30
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2038-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Osteoarthritis in the thumb base. Radiological Eaton class 1-3 (Ladd et al. 2015).
• Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

The inclusion criteria are identical to those of the control population.

Exclusion Criteria

• Rheumatoid arthritis.
• Ongoing infection in the hand or wrist.
• History of gout or pseudogout in the hand.
• Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
• Chronic pain syndrome / centralized pain.
• Intra-articular corticosteroid injection in the affected joint within 3 months. -Eaton Littler class 4 (symptomatic STT joint osteoarthritis).

The previously described exclusion criteria are identical to those of the control population. In addition patients with severe deformation of the trapezium, to the extent that it is not possible to place a prosthetic cup, will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain on load in the thumb 10 years postoperatively.	10 years postoperatively	Pain on load is rated with a self-administered 11-point numerical rating scale (NRS) 0-100 from the HQ-7 questionnaire. Higher score means more pain. The participants are asked to rate the pain the previous week.

Secondary Outcome Measures

Name	Time	Method
Pain on load in the thumb 3 and 6 months, 1, 3, and 5 years postoperatively.	from enrollment to 5 years postoperatively	Pain on load is rated with a self-administered 11-point numerical rating scale (NRS) 0-100 from the HQ-7 questionnaire. Higher score means mote pain. The participants are asked to rate the pain the previous week.
HQ-8 score 3 and 6 months, 1,3, 5 and 10 years postoperatively	From enrollment to 10 years postoperatively	Self-administered 11-point numerical rating scale (NRS) 0-100 symptoms questionnaire. Symptoms inlcude pain at rest, pain on motion, stiffness, weakness. Higher score means more symptoms. HQ-8 is the symptom-rating scale in the Swedish Hand surgical quality registry (HAKIR).
Patient-rated Wrist and Hand (PRWHE) score 3 and 6 months, 1,3, 5 and 10 years postoperatively	From enrollment to 10 years postoperatively	Patient-rated Wrist and Hand (PRWHE). Scale 0-100, higher score means more pain and disability,
Distability of the Arm, Hand and Shoulder (DASH) score 3 and 6 months, 1,3, 5 and 10 years postoperatively	From enrollment to 10 years postoperatively.	Distability of the Arm, Hand and Shoulder (DASH) score range from 0 to 100, higher score means more disability,
Thumb range of motion 3 and 6 months, 1,3, 5 and 10 years postoperatively	From enrollment to 10 years postoperatively	Palmar and radial abduction of the first metacarpal measured with a goniometer
Adverse events	From enrollment to 10 years postoperatively.	Number of particiant with a diagnosed infection, complex regional pain syndrome (CRPS), superficial radial sensory nerve injury or revision surgery required.
Hand strength 1,3, 5 and 10 years postoperatively	From enrollment to 10 years postoperatively	Key pinch, three-finger pinch and grip strength measured with a pinch gauge and Jamar, respectively (kg).

Trial Locations

Locations (1)

Handkirurgiska kliniken Södersjukhuset; 🇸🇪 Stockholm, Sweden