Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2) (GRIP 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03247439|
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : December 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Cartiva||Not Applicable|
This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC.
A total of 74 subjects will be enrolled into the pivotal study.
Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator|
|Actual Study Start Date :||December 22, 2017|
|Actual Primary Completion Date :||October 30, 2020|
|Estimated Study Completion Date :||March 2024|
Synthetic Cartilage Implant
Synthetic Cartilage Implant
- Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year ]Success criteria: ≥ 30% VAS decrease at 12 months. Visual Analog Scale (VAS) Pain score will be obtained from the subject for pain in the treated hand by completing a CRF, which has a 100 mm horizontal line on it, with the left end indicating that the subject has no pain and the right end of the line indicating a lot of pain. The subject will be instructed to place a mark on the horizontal line to rate the average pain in the treated thumb joint over the past week. The designated site staff will use a metric ruler to measure the markings made by the subject on the VAS to determine the VAS score.
- Function measured by QuickDASH [ Time Frame: 1 year ]Success criteria: ≥ 15.9 point decrease at 12 months. QuickDASH functional score will be obtained from the subject. The QuickDASH, the shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcomes Measures, is a region-specific, self-reported questionnaire that uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Subjects are asked to circle the appropriate response to each question based on their condition in the past week.
- Radiographic Findings [ Time Frame: 1 year ]Success criteria: Freedom from radiographic failures post-surgery through 12 months. Radiographic failures are defined as device dislocation, device fragmentation and/or development of avascular necrosis.
- Key Subsequent Secondary Surgical Interventions (SSSIs) [ Time Frame: 1 year ]Success criteria: Freedom from Subsequent Secondary Surgical Interventions (SSSIs) through 12 months. SSSIs are defined as revisions, removals, reoperations, and/or supplemental fixations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247439
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92093|
|United States, Georgia|
|Georgia Hand, Shoulder & Elbow|
|Atlanta, Georgia, United States, 30309|
|United States, Indiana|
|Indiana Hand to Shoulder Center|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Hospital for Specialty Surgery|
|New York, New York, United States, 10021|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Royal Derby Hospital|
|Derby, Derbyshire, United Kingdom, DE22 3NE|
|Dorset County Hospital|
|Dorchester, Dorset, United Kingdom, DT2 8DH|
|Queen Alexandra Hospital|
|Portsmouth, Hampshire, United Kingdom, PO6 3LY|
|South Tees Hospitals|
|Middlesborough, North Yorkshire, United Kingdom, TS4 3BW|
|Principal Investigator:||Scott Wolfe, MD||Hospital for Special Surgery, New York|
|Principal Investigator:||Christopher Bainbridge, MB ChB, FRCSEd, CCST||Royal Derby Hospital|