Evaluation of the Agili-C Biphasic Implant in the Knee Joint
|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: NCT01471236|
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Diseases Osteochondritis Dissecans||Device: Agili-C Bi-phasic Implant Procedure: mini-arthrotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Agili-c bi-phasic implant
Device: Agili-C Bi-phasic Implant
The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone).
The implant will be inserted gently in a pressed fit manner.
Other Name: Agili-C implant
The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator`s final decision. Related treatments during the procedure should be recorded.
Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded.
- improvement in KOOS pain subscales [ Time Frame: 24 months ]The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
- KOOS total score [ Time Frame: 24 months ]
- Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales.
- Change from baseline to 18 and 24 months visit in IKDC current health assessment.
- Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score.
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation
- Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit
- number of SAE [ Time Frame: 24 months ]Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471236
|Clinical Hospital ''Sveti Duh''|
|Fakultní nemocnice Brno|
|Brno, Czech Republic|
|Uzsoki Street Hospital|
|Rizzoli Orthopaedic Institute|
|County Hospital of Timisoara,|
|Timisoara, Romania, 300203|
|Institut za Ortopedsko-hirurške|
|Clinical center of Vojvodina|
|Novi Sad, Serbia|
|Principal Investigator:||Elizaveta Kon, MD|