Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

Study Overview
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Brief Summary
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The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively). Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

Detailed Description
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The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively). Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature. The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Official Title
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Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Device: Touch Dual Mobility CMC I Prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CMC I Osteoarthritis /Stage III) Exclusion Criteria: CMC I (osteoarthritis / Other Stage than III) Anticoagulation
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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective non randomized Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthesis Cohort<br>Surgery dual mobility Prosthesis | Device: Touch Dual Mobility CMC I Prosthesis<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH Score (Disability of Arm Shoulder and Hand Score) | DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Pain | patients report about subjective Pain level in average at 6, 12 and 24 months in a VAS (Visual Analog Pain Scale) scale (0-10), whereas 0 is best and 10 worst | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery