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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Osteoarthritis; Musculoskeletal Diseases or Conditions; Osteoarthritis Thumb; Arthrosis of First Carpometacarpal Joint
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

• Study Contact: Name: Miriam Marks, PhD; Phone Number: +41 44 385 75 81; Email: miriam.marks@kws.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Daniel B. Herren, Dr. med., Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: RSI; Touch® prothesis; Resection-suspension-interposition arthroplasty; Thumb carpometacarpal joint; Dual mobility prosthesis
• Additional Relevant MeSH Terms: Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: OE-0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No