Post Market Clinical Follow-Up TOUCH® CMC 1

September 4, 2025 updated by: Keri Medical SA

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France, 13090
        • Centre de la main du Pays d'Aix
      • Beaumont, France, 63110
        • Clinic of Chataigneraie
      • Bezannes, France, 51430
        • Orthopaedics and Trauma Surgery Practice
      • Challes-les-Eaux, France, 73190
        • Medipole de Savoie
      • Dijon, France, 21000
        • Medical Office of Dr TCHURUKDICHIAN
      • Lesquin, France, 59810
        • Medical Office Archimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility and pain
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keri Medical SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Actual)

February 22, 2022

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02352-55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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