Post Market Clinical Follow-Up TOUCH® CMC 1

NCT ID: NCT06546306

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2031-12-31

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.

Conditions

Osteoarthritis Thumb

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

TOUCH® CMC 1

TOUCH® prosthesis is a total CMC 1 (1st Carpo-metacarpal) joint replacement prosthesis.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keri Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de la main du Pays d'Aix

Aix-en-Provence, , France

Clinic of Chataigneraie

Beaumont, , France

Orthopaedics and Trauma Surgery Practice

Bezannes, , France

Médipôle De Savoie

Challes-les-Eaux, , France

Medical Office of Dr TCHURUKDICHIAN

Dijon, , France

Medical Office Archimed

Lesquin, , France

Countries

France

Other Identifiers

2019-A02352-55

Identifier Type: -

Identifier Source: org_study_id