Evaluation of the Agili-C Biphasic Implant in the Knee Joint
This trial is active, not recruiting.
|Conditions||cartilage diseases, osteochondritis dissecans|
|Treatments||agili-c bi-phasic implant, mini-arthrotomy|
|Sponsor||Cartiheal (2009) Ltd|
|Start date||June 2011|
|End date||December 2016|
|Trial size||65 participants|
|Trial identifier||NCT01471236, CLN0002|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Zagreb, Croatia||Clinical Hospital ''Sveti Duh''||no longer recruiting|
|Brno, Czech Republic||Fakultní nemocnice Brno||no longer recruiting|
|Budapest, Hungary||Uzsoki Street Hospital||no longer recruiting|
|Bologna, Italy||Rizzoli Orthopaedic Institute||no longer recruiting|
|Timisoara, Romania||County Hospital of Timisoara,||no longer recruiting|
|Belgrade, Serbia||Institut za Ortopedsko-hirurške||no longer recruiting|
|Novi Sad, Serbia||Clinical center of Vojvodina||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
improvement in KOOS pain subscales
time frame: 24 months
KOOS total score
time frame: 24 months
Male or female participants from 18 years up to 55 years old.
Inclusion Criteria 1. 18 to 55 years 2. Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau - Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage. - Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters. 3. Primary or secondary articular cartilage repair. 4. Knee is stable or can be stabilized as a concomitant procedure. 5. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits. 6. Signed informed consent. 7. Any misalignments should be fully corrected at the end of the operative procedure. Exclusion Criteria 1. Uncorrected axial misalignments >5° that cannot be corrected. 2. Patellar cartilage defects or pathology. 3. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair. 4. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present. 5. Active acute or chronic infection of the treated knee. 6. Inflammatory arthropathy or crystal-deposition arthropathy. 7. Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone. 8. Bony defect depth over 3 millimeters. 9. Body mass index >35. 10. Asymptomatic articular cartilage defects. 11. Bipolar articular cartilage defects. 12. Osteoarthritis of the operated knee. 13. Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy. - Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months - Any previous operation of cartilage treatment within the last 6 months 14. Patients who are sensitive to materials containing calcium carbonate or hyaluronate 15. Pregnant women, women who plan to become pregnant and breastfeeding women. 16. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the patient's welfare. 17. Substance abuse or alcohol abuse. 18. Participation in another clinical trials in parallel to this study. 19. Type I diabetes. 20. Unable to undergo MRI or X-ray. 21. Any reasons making the patient a poor candidate in the opinion of the investigator.
|Official title||Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects|
|Principal investigator||Elizaveta Kon, MD|
|Description||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.|
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