Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial

Study Overview
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Brief Summary
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Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.

Detailed Description
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Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis. Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength Complications are registered. The patients are observed for two years and the investigators aim to include a total of 40 patients.

Official Title
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Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb

Conditions
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Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Intervention / Treatment
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* Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)
* Procedure: Total joint replacement
* Device: Elektra prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CMC 1 arthritis Pain and dysfunction Adult patients General good health Exclusion Criteria: Pregnancy STT arthritis (CT scan preoperatively for all patients) Other injuries in thumb/hand

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trapeziektomi and ligament interposition<br>Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure) | Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)<br>* Burton-Pellegrini procedure<br>|
| Experimental: Total joint replacement<br>Elektra CMC1 uncemented prosthesis Elektra prosthesis | Procedure: Total joint replacement<br>* Total joint replacement<br>* Other names: Elektra prosthesis (Dijon, France);Device: Elektra prosthesis<br>* Elektra prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quick-DASH | two-page questionnaire with VAS-scale for pain and function. | Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nelson hospital score | one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528 | Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement