Study to Evaluate the Safety and Performance of Treatment of Articular Cartilage Lesions Located on the Femoral Condyle With gelrinC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00989794|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2009
Last Update Posted : October 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Lesion to the Femoral Condyle||Device: GelrinC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study for the Safety and Performance of GELRIN C|
|Study Start Date :||September 2009|
|Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||March 2019|
GelrinC one step implantation to the femoral condyle lesion
Applied once during surgery
- 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 ]