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Clinical Trials in France / NCT06546306
Active, not recruiting Observational

Post Market Clinical Follow-Up TOUCH® CMC 1

NCT06546306 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-11-22
Last updated
2025-09-11

Condition(s) studied

Osteoarthritis Thumb

Investigational drug(s) / intervention(s)

TOUCH® CMC 1

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546306 on ClinicalTrials.gov ↗ ← All trials in France