Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Isala
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Michigan Hand Outcomes Questionnaire (MHOQ)
Study Overview
Brief Summary
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •40 years of age or more
- •Symptomatic trapeziometacarpal osteoarthritis
- •Eaton & Glickel stage 4
Exclusion Criteria
- •An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
- •Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
- •Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- •Symptomatic carpal tunnel syndrome in same hand.
- •Symptomatic Quervain's tenosynovitis in same hand.
- •Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
- •Insufficient knowledge of Dutch language.
Outcomes
Primary Outcomes
Michigan Hand Outcomes Questionnaire (MHOQ)
Time Frame: 1 year after surgery
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Secondary Outcomes
- Michigan Hand Outcomes Questionnaire (MHOQ)(1 and 5 years after surgery)
- Disabilities of Arm Shoulder and Hand (DASH)(1 and 5 years after surgery)
- Grip strength(1 and 5 years after surgery)
- Thumb mobility(1 and 5 years after surgery)
- Complications(1 and 5 years after surgery)
- Return to work(1 and 5 years after surgery)
Investigators
Ramon de Wildt
MD
Isala