Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee (NCT04537013) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
Stopped: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.
United States, Canada82 participantsStarted 2020-08-26
Plain-language summary
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent
✓. One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
✓. Between 18 and 55 years of age
✓. Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol
Exclusion criteria
✕. BMI ≥ 30 kg/m2
✕. Symptomatic contralateral knee
✕. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
✕. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
✕. Patella dysplasia
✕
What they're measuring
1
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS