Status:
RECRUITING
TRACE - Thumb Base Replacement Arthroplasty for Osteoarthritis.
Lead Sponsor:
Karolinska Institutet
Conditions:
Osteoarthritis of the CMC-1 Joint
Eligibility:
All Genders
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2038
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07178223
Start Date
August 1 2025
End Date
December 31 2038
Last Update
September 23 2025
Active Locations (1)
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1
Handkirurgiska kliniken Södersjukhuset
Stockholm, Sweden, 11883