At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)
In Brief
An observational study evaluating Microfracture with BST-CarGel and Microfracture without BST-CarGel for Knee Injuries. Completed, enrolled 67 participants across 16 sites in 2 countries.
Detailed Summary
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.