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 impla
Sponsors
CartiHeal (2009) Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The KOOS Pain Subscale relative to baseline [time frame: 6, 12,18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| * Improvement in IKDC Subjective Knee Score relative to baseline [time frame: 6, 12,18 and 24 months] * Joint Space maintenance rate according to X-ray [time frame: 12 and 24 months] * Improvement in other KOOS subscales relative to baseline [time frame: 6, 12,18 and 24 months] * Improvement SF -36 Survey [time frame: 6, 12,18 and 24 months] * Improvement in Tegner score [time frame: 6, 12,18 and 24 months] * Improvement in Lysholm Score [time frame: 6, 12,18 and 24 months] * Defect Fill according to MRI [time frame: 6, 12, 18 and 24 months]D | — |
Countries
Netherlands
Outcome results
None listed