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NCT Number: NCT05849506

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

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.

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Key information

Conditions

Osteoarthritis Thumb Arthritis Arthrosis of First Carpometacarpal Joint Joint Diseases Musculoskeletal Diseases Musculoskeletal Diseases or Conditions Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Touch® Prosthesis

Device

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

Primary outcomes

  1. Patient satisfaction wiht treatment result using 5-point Likert scale

    Time frame: 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 outcomes

  1. Sociodemographic information

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

    Questionnaire

  2. Additional aspects of patient satisfaction with treatment

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

    Questionnaire

  3. Differences between both thumbs

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

    Questionnaire

  4. Brief Michigan Hand Outcomes Questionnaire (MHQ)

    Time frame: 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.

  5. Grip strength assessed with Jamar Dynamometer

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

    Jamar Dynamometer

  6. Key pinch strength assessed with pinch gauge

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

    Pinch gauge

  7. Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer

    Time frame: 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).

  8. Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS)

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

    NRS ranging from 0 (no pain) to 10 (worst pain)

  9. Radiographs of both thumbs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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