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

Sponsor

Schulthess Klinik (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05849506

Collaborator

(none)

Enrollment

Location

4.9

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Thumb Joint Diseases Musculoskeletal Diseases or Conditions Osteoarthritis Arthrosis of First Carpometacarpal Joint	Device: Touch® Prosthesis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

May 5, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Touch® Prosthesis The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.

Arm

Intervention/Treatment

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.

Device: Touch® Prosthesis

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

Outcome Measures

Primary Outcome Measures

Patient satisfaction wiht treatment result using 5-point Likert scale [Follow-up at least 3 months to 12 years after surgery]
5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied)

Secondary Outcome Measures

Sociodemographic information [Follow-up at least 3 months to 12 years after surgery]
Questionnaire
Additional aspects of patient satisfaction with treatment [Follow-up at least 3 months to 12 years after surgery]
Questionnaire
Differences between both thumbs [Follow-up at least 3 months to 12 years after surgery]
Questionnaire
Brief Michigan Hand Outcomes Questionnaire (MHQ) [Follow-up at least 3 months to 12 years after surgery]
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.
Grip strength assessed with Jamar Dynamometer [Follow-up at least 3 months to 12 years after surgery]
Jamar Dynamometer
Key pinch strength assessed with pinch gauge [Follow-up at least 3 months to 12 years after surgery]
Pinch gauge
Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer [Follow-up at least 3 months to 12 years after surgery]
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).
Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS) [Follow-up at least 3 months to 12 years after surgery]
NRS ranging from 0 (no pain) to 10 (worst pain)
Radiographs of both thumbs [Follow-up at least 3 months to 12 years after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.