Post Market Clinical Follow-Up TOUCH® CMC 1 (NCT06546306)

Study 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 studied

Osteoarthritis Thumb

In context

Lead sponsor

Keri Medical SA is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 216 participants (actual)
Patient registry: No

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 3 months

Study locations

6 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06546306
Lead sponsor: Keri Medical SA
Responsible party: Sponsor
First posted: Aug 9, 2024
Start date: Nov 22, 2019
Primary completion: Feb 22, 2022
Completion: Dec 2031 (estimated)
Last update: Sep 11, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Post Market Clinical Follow-Up TOUCH® CMC 1