Agili-C™ Implant Performance Evaluation

• ClinicalTrials.gov Identifier: NCT03299959
• Recruitment Status: Active, not recruiting
• First Posted: October 3, 2017
• Last Update Posted: February 11, 2020
• Sponsor: Cartiheal (2009) Ltd
• Information provided by (Responsible Party): Cartiheal (2009) Ltd

Tracking Information

• First Submitted Date: September 14, 2017
• First Posted Date: October 3, 2017
• Last Update Posted Date: February 11, 2020
• Actual Study Start Date: September 5, 2017
• Estimated Primary Completion Date: January 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 14, 2017)

KOOS Score [ Time Frame: Preoperative until 2 years postoperatively ]

Knee Injury and Osteoarthritis Outcome Score (KOOS)

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Agili-C™ Implant Performance Evaluation
• Official Title: 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
• Brief Summary: 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.

Detailed Description

This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Open-label Randomized Controlled Trial

Masking: None (Open Label)
Masking Description:

Open-Label, adaptive design with interim analyses

Primary Purpose: Treatment

Condition

• Cartilage or Osteochondral Defects in the Knee
• Up to Moderate Osteoarthritis

Intervention

• Device: Agili-C implant
  Agili-C implant
• Procedure: SSOC
  microfracture and/or debridement

Study Arms

• Experimental: Agili-C
  Intervention: Device: Agili-C implant
• Active Comparator: Surgical Standard of Care (SSOC)
  Intervention: Procedure: SSOC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 9, 2020): 251
• Original Enrollment: Not Provided
• Estimated Study Completion Date: January 1, 2023
• Estimated Primary Completion Date: January 1, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Hungary, Israel, Italy, Poland, Romania, Serbia, United States
• Removed Location Countries: France, Slovenia

Administrative Information

• NCT Number: NCT03299959
• Other Study ID Numbers: CLN0021
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Cartiheal (2009) Ltd
• Study Sponsor: Cartiheal (2009) Ltd
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elizaveta Kon, MD; Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy

• PRS Account: Cartiheal (2009) Ltd
• Verification Date: February 2020