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

NCT05849506 | Completed

• 1 other identifier: OE-0203
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction wiht treatment result using 5-point Likert scale

  5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied)

  Follow-up at least 3 months to 12 years after surgery

Secondary Outcomes (9)

• Sociodemographic information

  Follow-up at least 3 months to 12 years after surgery

• Additional aspects of patient satisfaction with treatment

  Follow-up at least 3 months to 12 years after surgery

• Differences between both thumbs

  Follow-up at least 3 months to 12 years after surgery

• Brief Michigan Hand Outcomes Questionnaire (MHQ)

  Follow-up at least 3 months to 12 years after surgery

• Grip strength assessed with Jamar Dynamometer

  Follow-up at least 3 months to 12 years after surgery

Study Arms (1)

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

Interventions

Touch® Prosthesis DEVICE

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

Touch-RSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient with any type of revision surgery at the CMC I joint
• Patient underwent hand surgery within the last three months
• Legal incompetence

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Study Officials

• Daniel B. Herren, Dr. med.

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 9, 2023
• Study Start: June 21, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)