articular cartilage lesion
Conditions
Interventions
Each study participant will receive the Agili-C bi-phasic Implant: this trial
is single-arm, meaning that all the patients enrolled in the trial will undergo
the implantation of the device.
The impl
Sponsors
Cartihael (2009) Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 55 years 2. Symptomatic, Painful, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral (grade 1,2,3,4A) isolated lesion of the femoral condyle, trochlea or the tibial plateau (limited to 4 millimeters in depth). 3. KOOS pain score is
Exclusion criteria
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. Present or past acute or chronic infection of the treated knee. 6. Inflammatory arthropathy or crystal-deposition arthropathy. 7. Systemic cartilage and/or bone disorder; This implant's integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone 8. Bony defect depth over 4 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 the surgery or chemotherapy. 14. Previous arthroscopic marrow stimulation or cell therapy within the last 6 months 15. Any previous cartilage treatment within the last 6 months 16. Patients who are sensitive to materials containing calcium carbonate or hyaluronate. 17. Pregnant women, Women of Childbearing Potential [WOCBP-defined as any female who has experienced menarche and does not meet the criteria for *Women Not of Childbearing Potential* which are: women who are postmenopausal,permanently sterilised (e.g. tubal ligation, hysterectomy, bilateral salpingectomy)], women who are not using a highly effective contraception method (as defined by ICH M3) during the entire duration of the clinical trial or breastfeeding women. 18. 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 Subject's welfare. 19. Substance abuse or alcohol abuse. 20. Participation in other clinical trials in parallel to this study. 21. Type I diabetes. 22. Unable to undergo MRI or X-ray. 23. Any reasons making the Subject a poor candidate in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in KOOS Pain Subscale | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in KOOS Score and Subscales • Improvement in IKDC Subjective Knee Score (and VAS as part of it) • Improvement in Knee Examination Form - 2000 • Improvement in SF 36 Questionnaire • Improvement in Tegner score • Improvement in Lysholm Knee Coring Scale • Improvement in new MOCART Scoring | — |
Countries
Netherlands
Outcome results
None listed