Post Market Clinical Follow-Up TOUCH® CMC 1

Active, not recruiting

• Conditions: Osteoarthritis Thumb

• Registration Number: NCT06546306
• Lead Sponsor: Keri Medical SA

Brief Summary

Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.

The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).

The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.

Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-22
• Primary Completion: 2022-02-22
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Adult patients (age ≥ 18 years),
• Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
• Pain >3 on the VAS scale,
• Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.

Exclusion Criteria

• Pregnant women,
• Patients with contraindications to surgery in general,
• Patients suffering from Temporary Regional Pain Syndrome (TRPS),
• Patients with a severe or chronic, local or systemic infection,
• Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
• Patients with bone demineralization or destruction that may affect the proper fixation of the implant,
• Patients whose bone dimensions are incompatible with the implant dimensions,
• The combination of the Touch® prosthesis with other components of another origin is not authorized,
• Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel),
• Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon,
• Patient with scaphoid-trapezium-trapezoid (STT) arthritis,
• Patient requiring revision of a trapeziometacarpal prosthesis,
• Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mobility and pain	3 months	At 3 months post-surgery, the proportion of patients with a Kapandji score \> 8 and a pain score ≤ 3 on a VAS scale.

Trial Locations

Locations (6)

Clinic of Chataigneraie; 🇫🇷 Beaumont, France

Centre de la main du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

Medical Office Archimed; 🇫🇷 Lesquin, France

Orthopaedics and Trauma Surgery Practice; 🇫🇷 Bezannes, France

Medical Office of Dr TCHURUKDICHIAN; 🇫🇷 Dijon, France

Médipôle De Savoie; 🇫🇷 Challes-les-Eaux, France