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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Synthetic Cartilage Implant
University of California, San Diego
San Diego, California, United States
Georgia Hand, Shoulder & Elbow
Atlanta, Georgia, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
Hospital for Specialty Surgery
Pain measured by the Visual Analog Scale (VAS) scale
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.
Time frame: 1 year
Function measured by QuickDASH
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.
Time frame: 1 year
Radiographic Findings
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.
Time frame: 1 year
Key Subsequent Secondary Surgical Interventions (SSSIs)
Success criteria: Freedom from Subsequent Secondary Surgical Interventions (SSSIs) through 12 months. SSSIs are defined as revisions, removals, reoperations, and/or supplemental fixations.
Time frame: 1 year
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New York, New York, United States
University of Rochester
Rochester, New York, United States
Royal Derby Hospital
Derby, Derbyshire, United Kingdom
Dorset County Hospital
Dorchester, Dorset, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
South Tees Hospitals
Middlesbrough, North Yorkshire, United Kingdom