Clinical trial NCT05849506: Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results
Official title: Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results: An Ambidirectional Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis Thumb
Joint Diseases
Musculoskeletal Diseases or Conditions
Osteoarthritis
Arthrosis of First Carpometacarpal Joint
Keywords: Touch® prothesis
RSI
Resection-suspension-interposition arthroplasty
Thumb carpometacarpal joint
Dual mobility prosthesis
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients with CMC I joint osteoarthritis. They have a Touch® prosthesis in one thumb and an RSI arthroplasty in the other.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction wiht treatment result using 5-point Likert scale
timeFrame: Follow-up at least 3 months to 12 years after surgery
Secondary outcomes:
measure: Sociodemographic information
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Additional aspects of patient satisfaction with treatment
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Differences between both thumbs
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Brief Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Grip strength assessed with Jamar Dynamometer
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Key pinch strength assessed with pinch gauge
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS)
timeFrame: Follow-up at least 3 months to 12 years after surgery
measure: Radiographs of both thumbs
timeFrame: Follow-up at least 3 months to 12 years after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Daniel B. Herren, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: