Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 3/24/2019 |
Start Date: | December 22, 2017 |
End Date: | January 2024 |
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
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.
osteoarthritis of the first CMC joint in the hand compared to LRTI.
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.
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.
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
- Be willing and able to return for all study-related follow up procedures
Exclusion Criteria:
- Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
- History of or current diagnosis of rheumatoid arthritis
- OA of the scaphotrapeziotrapezoidal (STT) joint based on radiographic assessment in
the hand to be treated
- Any disease, including uncontrolled diabetes mellitus, which is clinically known to
impact wound healing ability
- Known or suspected allergic reaction to polyvinyl alcohol
We found this trial at
7
sites
Derby, Derbyshire
Principal Investigator: Christopher Bainbridge, MB ChB, FRCS
Phone: 01332 787491
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Charles Cassidy, MD
Phone: 617-636-5159
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Warren Hammert, MD
Phone: 585-341-9436
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Indianapolis, Indiana 46260
Principal Investigator: Gregory Merrell, MD
Phone: 317-471-4312
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535 East 70th Street
New York, New York 10021
New York, New York 10021
Principal Investigator: Scott Wolfe, MD
Phone: 646-714-6640
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