Agili-C™ Implant Performance Evaluation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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 29.

Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03299959
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cartiheal (2009) Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elizaveta Kon, MD
Principal Investigator Affiliation	Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Belgium, Hungary, Israel, Italy, Poland, Romania, Serbia, Slovenia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis

Additional Details

This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs.#46; SSOC for the repair of joint surface lesions. Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18 and 24 months post-procedure to evaluate the patient's knee condition and clinical health. The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18 and 24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.

Arms & Interventions

Arms

Experimental: Agili-C

Active Comparator: Surgical Standard of Care (SSOC)

Interventions

Device: - Agili-C implant

Agili-C implant

Procedure: - SSOC

microfracture and/or debridement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson Orthopedic Institute, Tucson, Arizona

Status

Recruiting

Address

Tucson Orthopedic Institute

Tucson, Arizona, 85712

Site Contact

Clinical Trial Finder