Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial (NCT05644132) | Clinical Trial Compass
CompletedNot Applicable
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Belgium15 participantsStarted 2021-08-06
Plain-language summary
This clinical trial aims to evaluate the safety and effectiveness of the lnDx Implant in the treatment of thumb base joint arthritis.
This clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.
Participants will undergo the following measures to assess their clinical performance:
* Hand X-Ray
* Range of Motion - Kapandji opposition score
* Grip strength, lateral pinch and tip pinch
* Visual Analogue Scale (VAS) for Pain
* Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
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 1-111 osteoarthritis of the CMG joint on clinical examination and X-ray;
* 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;
* Be willing and able to return for all study-related follow-up procedures;
* If female, is either using contraception or is postmenopausal, or male partner is using contraception; and
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the institutional review board/ethics committee.
Exclusion Criteria:
* The patient is \<18 years of age;
* The patient is suffering from Rheumatoid Arthritis;
* The patient is suffering from Grade IV osteoarthritis of the CMG joint;
* The patient is suffering post-traumatic arthritis of the CMG joint;
* 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;
* Metal or polymer material sensitivity;
* Patients who are unwilling or incapable of following postoperative care instructions or protocol requirements;
* Muscular imbalance, peripheral …
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.