Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Co… (NCT03247439) | Clinical Trial Compass
UnknownNot Applicable
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
United States, United Kingdom74 participantsStarted 2017-12-22
Plain-language summary
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the first CMC joint in the hand compared to LRTI.
Who can participate
Age range
22 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:
* ≥ 22 years of age
* Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention
* Eaton classification stage II or III OA of the first CMC joint based on X-rays taken within 6 months of the Operative date and evidence of first CMC joint OA based on subjective review of associated clinical symptoms
* Preoperative VAS Pain score of ≥ 40 in the treated hand
* Preoperative 11 question QuickDASH score of ≥ 20
* Presence of good bone stock - i.e., no need for bone graft
* Capable of completing self-administered questionnaires
* Be willing and able to return for all study-related follow up procedures
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/REB/Ethics Committee
Exclusion Criteria:
* Active systemic infection
* Active infection at the site of surgery
* Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
* Inflammatory arthropathy and/or diagnosis of grout
* History of or current diagnosis of rheumatoid arthritis
* Any significant bone loss, avascular necrosis, or cyst \> 8mm of the supporting bone structure
* Eaton classification stage IV advanced OA of the first CMC joint based on X-rays taken within 6 months of the Operative date
* Physical conditions that would tend to eliminate adequate implant support (e.g., inadequate cortical bone stock of a…
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
1
Pain measured by the Visual Analog Scale (VAS) scale