Study to Evaluate the Safety and Performance of Treatment of Articular Cartilage Lesions Located on the Femoral Condyle With gelrinC
This is a single arm, open label multi-center study to determine safety and the performance of the treatment of cartilage lesions located on the femoral condyle with GelrinC.
Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study, and will receive treatment implantation into their cartilage lesions.
Treatment will consist of GelrinC implantations at the symptomatic lesion of femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate.
The patients will undergo a rehabilitation program during the follow up period.
|Cartilage Lesion to the Femoral Condyle||Device: GelrinC||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study for the Safety and Performance of GELRIN C|
- No device related AE, or SAE [ Time Frame: 1 year ]
- Improvement in KOOS over baseline [ Time Frame: 18 months ]
- improvement in outcome based on questionnaires (KOOS, IKDC, VAS, SF-36) [ Time Frame: 2 years ]
- improvement in outcome based on MRI (MOCART) [ Time Frame: 2 years ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||March 2019|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
GelrinC one step implantation to the femoral condyle lesion
Applied once during surgery