Agili-C Implant Performance Evaluation in the Repair of Cartilage and OCD - Agili-C AMC trial

CartiHeal (2009) Ltd.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. 18 years or older
•2. Cartilage lesion of the operated knee graded up to grade III according to the Kelgren- Lawrence scale with known ICRS IIIa * IVb lesion (s) on the femoral condyles or the trochlea, not eligible for microfracture and who failed conservative treatment
•3. The total area of the treated lesions is up to 6 cm2
•4. KOOS pain score at baseline is not less than 30 and not more than 65
•5. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical and radiographic visits.
•6. Informed consent signing

•1. Untreated ACL and/or PCL, ACL and/or PCL deficiency or ligamentous instability in involved knee
•2. Misalignments larger than 5° from neutral that are not correctable
•3. Any known tumor of the ipsilateral knee
•4. Any history of infection of the treated knee
•5. Inflammatory arthropathy or crystal-deposition arthropathy
•6. Tobacco user
•7. Systemic cartilage and/or bone disorder e.g. but not limited to chondrodysplasia or osteogenesis imperfecta
•8. Body mass index >35
•9. Osteoarthritis of the operated knee graded as 4 according to the Kelgren-Lawrence scale
•10. Chemotherapy treatment in the past 12 months
•11. Any previous surgical cartilage treatment within the last 6 months
•12. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
•13. Patient who is pregnant or intends to become pregnant during the year following initial enrollment
•14. History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV
•infection; known coagulopathies, that might compromise the Subject's welfare
•15. Known Substance abuse or alcohol abuse
•16. Participation in other clinical trials in parallel to this study
•17. Known insulin dependent diabetes mellitus
•18. Unable to undergo MRI or X-ray

发起方