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

Completed

• Conditions: Osteoarthritis; Arthrosis of First Carpometacarpal Joint; Musculoskeletal Diseases or Conditions; Joint Diseases; Osteoarthritis Thumb
• Interventions: Device: Touch® Prosthesis

• Registration Number: NCT05849506
• Lead Sponsor: Schulthess Klinik

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.

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 Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-09
• Study Start: 2023-06-21
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Touch-RSI	Touch® Prosthesis	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Key pinch strength assessed with pinch gauge	Follow-up at least 3 months to 12 years after surgery	Pinch gauge
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.
Differences between both thumbs	Follow-up at least 3 months to 12 years after surgery	Questionnaire
Grip strength assessed with Jamar Dynamometer	Follow-up at least 3 months to 12 years after surgery	Jamar Dynamometer
Additional aspects of patient satisfaction with treatment	Follow-up at least 3 months to 12 years after surgery	Questionnaire
Sociodemographic information	Follow-up at least 3 months to 12 years after surgery	Questionnaire
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).
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.

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland