Active — Not RecruitingNot Applicable

Post Market Clinical Follow-Up TOUCH® CMC 1

France216 participantsStarted 2019-11-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mobility and pain

Timeframe: 3 months

Trial details

NCT IDNCT06546306

SponsorKeri Medical SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-02-22

View on ClinicalTrials.gov More Osteoarthritis Thumb trials