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 States74 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 range22 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:
* ≥ 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…
What they're measuring
1
Pain measured by the Visual Analog Scale (VAS) scale