Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results

Study Overview
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Brief Summary
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The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.

Detailed Description
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Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.

Official Title
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Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results: An Ambidirectional Trial

Conditions
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Osteoarthritis Thumb, Joint Diseases, Musculoskeletal Diseases or Conditions, Osteoarthritis, Arthrosis of First Carpometacarpal Joint

Intervention / Treatment
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* Device: Touch® Prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent signed by the patient. Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb. Exclusion Criteria: Patient with any type of revision surgery at the CMC I joint Patient underwent hand surgery within the last three months Legal incompetence

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Touch-RSI<br>The group consists of patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb. Intervention: Patient questionnaire and clinical examination to investigate differences between the thumb with a Touch® implant and the thumb with an RSI. | Device: Touch® Prosthesis<br>* The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction wiht treatment result using 5-point Likert scale | 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied) | Follow-up at least 3 months to 12 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic information | Questionnaire | Follow-up at least 3 months to 12 years after surgery | 
| Additional aspects of patient satisfaction with treatment | Questionnaire | Follow-up at least 3 months to 12 years after surgery | 
| Differences between both thumbs | Questionnaire | Follow-up at least 3 months to 12 years after surgery | 
| Brief Michigan Hand Outcomes Questionnaire (MHQ) | The german version of the brief MHQ will be used to assess patient-reported hand function. The score ranges from 0 to 100 with higher scores indicating better hand function. | Follow-up at least 3 months to 12 years after surgery | 
| Grip strength assessed with Jamar Dynamometer | Jamar Dynamometer | Follow-up at least 3 months to 12 years after surgery | 
| Key pinch strength assessed with pinch gauge | Pinch gauge | Follow-up at least 3 months to 12 years after surgery | 
| Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer | Used to measure flexion and extension of the thumb metacarpal (MCP) and interphalangeal (IP) joint. The evaluation of active thumb opposition is based on the Kapandji index, ranging from 1 (can touch only the lateral side of the index finger) to 10 (can reach the volar crease of the hand). | Follow-up at least 3 months to 12 years after surgery | 
| Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS) | NRS ranging from 0 (no pain) to 10 (worst pain) | Follow-up at least 3 months to 12 years after surgery | 
| Radiographs of both thumbs | To monitor the implant and to assess the scaphometacarpal distance, which can be used to identify migration of the thumb metacarpal bone, a phenomenon often observed after trapeziectomy. | Follow-up at least 3 months to 12 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Touch® prothesis, RSI, Resection-suspension-interposition arthroplasty, Thumb carpometacarpal joint, Dual mobility prosthesis