Agili-C™ Implant Performance Evaluation

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-003562
    NCT ID: NCT03299959
    Sponsor Protocol Number: CLN0021

About this study

The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 post-operative 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/X-ray/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
  7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
  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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Open for enrollment

Contact information:

Jennifer Krogman

(507)538-3562

Krogman.Jennifer@mayo.edu