NCT06546306

Post Market Clinical Follow-Up TOUCH® CMC 1

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.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: Keri Medical SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-11-22
• Primary completion: 2022-02-22
• Completion: 2031-12-01
• First posted: 2024-08-09
• Last updated: 2025-09-11

Locations

6 sites across 1 country: France