Post Market Clinical Follow-Up TOUCH® CMC 1 | NCT06546306

Studies
Post Market Clinical Follow-Up TOUCH® CMC 1

NCT06546306

Sponsor

Keri Medical SA

Status

Active, not recruiting

Last Update Posted

Sep 11, 2025Actual

Enrollment

216Actual

Phase

Not provided

Conditions

Osteoarthritis Thumb

Interventions

TOUCH® CMC 1

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2019Actual

Primary Completion Date

Feb 22, 2022Actual

Completion Date

Dec 2031Estimated

First Submitted Date

Aug 6, 2024

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2025

Last Update Posted Date

Sep 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

216Actual

Name	Type	Description	Arm Group Labels	Other Names
TOUCH® CMC 1	Device	TOUCH® prosthesis is a total CMC 1 (1st Carpo-metacarpal) joint replacement prosthesis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Centre de la main du Pays d'Aix		Aix-en-Provence		13090	France
Clinic of Chataigneraie