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ACTIVE NOT RECRUITING
NCT06546306

Post Market Clinical Follow-Up TOUCH® CMC 1

Sponsor: Keri Medical SA

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of the Touch® Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis: Post-market Observational Clinical Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

216

Start Date

2019-11-22

Completion Date

2031-12

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DEVICE

TOUCH® CMC 1

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

Locations (6)

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