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 range18 Years
SexALL
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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…