Evaluation of the Agili-C Biphasic Implant in the Knee Joint
|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 implantProcedure: mini-arthrotomy
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
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|