The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.
Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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.
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.
Clinical Hospital ''Sveti Duh''
Zagreb, Croatia
Fakultní nemocnice Brno
Brno, Czechia
Uzsoki Street Hospital
Budapest, Hungary
Rizzoli Orthopaedic Institute
Bologna, Italy
improvement in KOOS pain subscales
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
Time frame: 24 months
KOOS total score
* 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
Time frame: 24 months
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Katowice, Poland
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Timișoara, Romania
Institut Za Ortopediju "Banjica"
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University Medical Centre, Ljubljana
Ljubljana, Slovenia