Clinical Trials Directory

Trials / Completed

CompletedNCT05849506

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
14 (actual)
Sponsor
Schulthess Klinik · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

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

Timeline

Start date
2023-06-21
Primary completion
2024-02-10
Completion
2024-02-10
First posted
2023-05-09
Last updated
2024-04-17

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05849506. Inclusion in this directory is not an endorsement.