Post Market Clinical Follow-Up TOUCH® CMC 1

NCT06546306 | Active Not Recruiting

• 1 other identifier: 2019-A02352-55
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 6

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 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

Outcome Measures

Primary Outcomes (1)

• Mobility and pain

  At 3 months post-surgery, the proportion of patients with a Kapandji score \> 8 and a pain score ≤ 3 on a VAS scale.

  3 months

Interventions

TOUCH® CMC 1 DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any type of population requiring a surgical procedure covered by the device indications and contraindications.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keri Medical SA: lead

Study Sites (6)

Centre de la main du Pays d'Aix

Aix-en-Provence, 13090, France

Location

Clinic of Chataigneraie

Beaumont, 63110, France

Location

Orthopaedics and Trauma Surgery Practice

Bezannes, 51430, France

Location

Médipôle De Savoie

Challes-les-Eaux, 73190, France

Location

Medical Office of Dr TCHURUKDICHIAN

Dijon, 21000, France

Location

Medical Office Archimed

Lesquin, 59810, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 22, 2019
• Primary Completion: February 22, 2022
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)