Agili-C Bi-phasic Implant Performances

Inclusion Criteria:

1. 18 to 55 years
2. Symptomatic, single, focal, full or near full-thickness (ICRS grades 3 and 4) chondral or osteochondral isolated lesion, less than 2 cm², involving the medial and lateral femoral condyles or the trochlea
3. Primary or secondary articular cartilage repair
4. Knee is ligamently stable or can be stabilized as a concomitant procedure
5. Meniscal resection of less than 50%, either in a previous procedure or concomitant with articular cartilage repair
6. The contralateral knee is asymptomatic, stable and fully functional
7. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits
8. Signed informed consent
9. Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period

Exclusion Criteria:

1. Advanced degenerative joint changes (joint space narrowing >50%)
2. Uncorrected axial malalignment >5° for femoral defects
3. Uncorrected patellar maltracking or instability for patellofemoral lesions
4. >50% meniscal deficiency
5. Tumor
6. Active acute or chronic infection of the treated knee
7. Inflammatory arthropathy
8. Systemic cartilage and/or bone disorder
9. Defect size > 2 cm²
10. Body mass index >30
11. Asymptomatic defects
12. Bipolar defects
13. More than one cartilage lesion
14. Osteoarthritis of either knee
15. Osteophyte formation

16. Nonoperative Treatment:

    • Intra-articular injections:

      • Steroid injection < 4 weeks,
      • Viscosupplementation < 3 months,
      • Autologous blood-derived growth factor concentrate < 3 months

    • Oral medications:

      • Anti-inflammatory medication < 1 week,
      • Glucosamine and chondroitin sulfate < 2 weeks,
      • Systemic corticosteroid therapy < 4 weeks

17. Operative Treatment:

    • Partial meniscectomy < 6 months,
    • Arthroscopic debridement or any marrow stimulation technique < 6 months,
    • Chondroplasty (calcified cartilage intact) < 6 months,
    • Synovectomy < 6 months,
    • Lateral release < 6 months,
    • Meniscus repair < 6 months,
    • Ligament reconstruction (ACL, PCL, MCL, MPFL) < 6 months,
    • Tibial or femoral osteotomy < 12 months,
    • Microfracture < 12 months,
    • Chondroplasty (through calcified cartilage) < 12 months
18. Hyaluronic acid sensitivity/ allergy
19. Pregnant women, women who plan to become pregnant and breastfeeding women.
20. Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
21. Substance or alcohol abuse
22. Participation in concurrent trials
23. Uncontrolled diabetes
24. Unable to undergo MRI or X-ray
25. Any reasons making the patient a poor candidate in the opinion of the investigator