Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the S… (NCT06467760) | Clinical Trial Compass
RecruitingNot Applicable
Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant
Belgium73 participantsStarted 2025-03-19
Plain-language summary
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.
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:
* The patient is at least 18 years of age;
* The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on clinical examination and X-ray;
* The patient is eligible for surgical treatment of CMC I arthrosis in the opinion of the investigator.
* The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
* The patient is able to understand the aims and objectives of the trial and is willing to consent;
* The patient is willing and able to return for all study-related follow-up procedures;
* If the patient is female, is either using contraception or is postmenopausal, or male partner is using contraception
Exclusion Criteria:
* The patient is suffering from Rheumatoid arthritis in the index hand;
* The patient is suffering from Grade IV osteoarthritis of the CMC joint;
* The patient is suffering post-traumatic arthritis of the CMC joint in the index hand;
* The patient is a pregnant/lactating female (tested as per institutional requirements);
* Active or latent infection, or sepsis;
* Insufficient quantity or quality of bone and/or soft tissue in the index hand;
* Metal or polymer material sensitivity;
* Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting s…
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.