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

NCT ID: NCT05849506

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-21

Study Completion Date

2024-02-10

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Touch-RSI

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.

Touch® Prosthesis

Intervention Type DEVICE

The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.

Interventions

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Touch® Prosthesis

The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel B. Herren, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

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Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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OE-0203

Identifier Type: -

Identifier Source: org_study_id

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