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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06546306

Enrollment

216

Registered

2024-08-09

Start date

2019-11-22

Completion date

2031-12-31

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Thumb

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.

Interventions

DEVICETOUCH® CMC 1

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026