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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849506
• Other study ID #: OE-0203
• Status: Completed
• Start date: June 21, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: April 2024
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrosis of First Carpometacarpal Joint
• Joint Diseases
• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions
• Osteoarthritis
• Osteoarthritis Thumb

Intervention

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

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sociodemographic information	Questionnaire	Follow-up at least 3 months to 12 years after surgery
Secondary	Additional aspects of patient satisfaction with treatment	Questionnaire	Follow-up at least 3 months to 12 years after surgery
Secondary	Differences between both thumbs	Questionnaire	Follow-up at least 3 months to 12 years after surgery
Secondary	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
Secondary	Grip strength assessed with Jamar Dynamometer	Jamar Dynamometer	Follow-up at least 3 months to 12 years after surgery
Secondary	Key pinch strength assessed with pinch gauge	Pinch gauge	Follow-up at least 3 months to 12 years after surgery
Secondary	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
Secondary	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
Secondary	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