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Post Market Clinical Follow-Up TOUCH® CMC 1
Sponsor: Keri Medical SA
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
Conditions
Interventions
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