Status:
ACTIVE_NOT_RECRUITING
Post Market Clinical Follow-Up TOUCH® CMC 1
Lead Sponsor:
Keri Medical SA
Conditions:
Osteoarthritis Thumb
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2031
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06546306
Start Date
November 22 2019
End Date
December 1 2031
Last Update
September 11 2025
Active Locations (6)
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1
Centre de la main du Pays d'Aix
Aix-en-Provence, France, 13090
2
Clinic of Chataigneraie
Beaumont, France, 63110
3
Orthopaedics and Trauma Surgery Practice
Bezannes, France, 51430
4
Médipôle De Savoie
Challes-les-Eaux, France, 73190