A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

This Study is
No Longer Enrolling

Description

The Agili-C™ scaffold is indicated for the treatment of an ICRS grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2 and without severe osteoarthritis (Kellgren-Lawrence grade 0-3)

Details
Age

Adult

Eligibility

1. 21 -75 years 2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea 3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation

Inclusion Criteria: 1. 21 -75 years 2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea 3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation 4. Must be physically and mentally willing and able to comply with the postoperative rehabilitation protocol and scheduled clinical and radiographic visits 5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable) 6. Non-responsive to physical therapy for at least 3-4 weeks Exclusion Criteria: 1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100) 2. Bony defect depth deeper than 8mm, according to baseline MRI/Xray/arthroscopy 3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above 4. Osteoarthritis of the index knee graded 4 according to the Kellgren- Lawrence Grading 5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal) 6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray 8. Meniscal transplantation in the past 6 months 9. Any known tumor of the index knee 10. Any known history of intra-articular or osseous infection of the index knee 11. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other) 12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy 13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta 14. Body Mass Index (BMI) > 35 15. Chemotherapy in the past 12 months 16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months 17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months 18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate 19. Patient who is pregnant or intends to become pregnant during the study 20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies 21. Known substance or alcohol abuse 22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study 23. Known insulin dependent diabetes mellitus 24. Unable to undergo either MRI or X-ray 25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed 26. Previous intra-articular steroid injection within the last 1 month 27. Prisoners 28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy 29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Outcomes Research

Locations

Boulder Sports Clinic
University of Colorado Hospital

Study ID

Protocol Number: 18-2105

More information available at ClinicalTrials.gov: NCT03299959

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