Clinical trial NCT06546306: Post Market Clinical Follow-Up TOUCH® CMC 1
Official title: 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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis Thumb
Lead sponsor: Keri Medical SA
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any type of population requiring a surgical procedure covered by the device indications and contraindications.

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.


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.

Primary outcomes:
measure: Mobility and pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre de la main du Pays d'Aix
city: Beaumont
country: France
facility: Clinic of Chataigneraie
city: Bezannes
country: France
facility: Orthopaedics and Trauma Surgery Practice
city: Challes-les-Eaux
country: France
facility: Médipôle De Savoie
city: Dijon
country: France
facility: Medical Office of Dr TCHURUKDICHIAN
city: Lesquin
country: France
facility: Medical Office Archimed
Study officials:
References: