Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Study Overview
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Brief Summary
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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. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate. We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.

Official Title
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Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial

Conditions
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Trapeziometacarpal Osteoarthritis, Thumb Carpometacarpal Osteoarthritis

Intervention / Treatment
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* Procedure: Total Joint Arthroplasty
* Procedure: Trapeziectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women. 40 years of age or more. Symptomatic trapeziometacarpal osteoarthritis. Eaton & Glickel stage 2 and 3. 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Joint Arthroplasty<br>Total Joint Arthroplasty | Procedure: Total Joint Arthroplasty<br>* Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France<br>|
| Active Comparator: Trapeziectomy<br>Trapeziectomy | Procedure: Trapeziectomy<br>* Trapeziectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michigan Hand Outcomes Questionnaire (MHOQ) | 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)? | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michigan Hand Outcomes Questionnaire (MHOQ) | Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)? | 5 years after surgery | 
| Michigan Hand Outcomes Questionnaire (MHOQ) | Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)? | 1 and 5 years after surgery | 
| Disabilities of Arm Shoulder and Hand (DASH) | Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)? | 1 and 5 years after surgery | 
| Grip strength | Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? | 1 and 5 years after surgery | 
| Thumb mobility | Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? | 1 and 5 years after surgery | 
| Complications | Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? | 1 and 5 years after surgery | 
| Return to work | Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? | 1 and 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Thumb, Total joint arthroplasty, Trapeziectomy