Agili-C™ Implant Performance Evaluation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cartilage or Osteochondral Defects in the Knee; Up to Moderate Osteoarthritis
• Intervention / Treatment: Device: Agili-C implant; Procedure: SSOC

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
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • AZ Monica
• Hungary
  • Budapest, Hungary, 1114
    • Uzsoki Utcai Kórház
  • Tata, Hungary, 2892
    • Kastélypark Klinika
• Israel
  • Be'er Ya'aqov, Israel, 60930
    • Assaf Harofeh Medical Center
  • Haifa, Israel, 3436212
    • "Carmel" Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Petach Tikva, Israel
    • Hasharon Hospital, Petach Tikva
  • Tel Aviv, Israel, 6423906
    • Souraski Medical Center
• Italy
  • Bergamo, Italy
    • Humanitas Gavazzeni
  • Rozzano, Italy
    • Istituto Clinico Humanitas
• Poland
  • Kraków, Poland
    • Specialist Hospital. Louis Rydygier in Krakow
• Romania
  • Timişoara, Romania
    • County Hospital Timis Othopedy and Trauma Clinic
• Serbia
  • Belgrade, Serbia
    • Atlas General hospital
  • Belgrade, Serbia
    • Clinic for Orthopedic Surgery "Banjica"
  • Novi Sad, Serbia
    • Clinical Center of Vojvodina
• United States
  • California
    • San Diego, California, United States, 91942
      • Horizon Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Healthcare Network Orthopedic & Sports Medicine
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Peninsula Orthopaedic Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02467
      • Brigham and Women's Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri, Missouri Orthopaedic Institute
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10003
      • NYU Langone Orthopedic Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University, Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Arlington, Texas, United States, 76015
      • Arlington Orthopedic Associates
  • Virginia
    • Richmond, Virginia, United States, 23294
      • OrthoVirginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Agili-C	Device: Agili-C implant; Agili-C implant
ACTIVE_COMPARATOR: Surgical Standard of Care (SSOC)	Procedure: SSOC; microfracture and/or debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS Score	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Preoperative until 2 years postoperatively

Collaborators and Investigators

• Sponsor: Cartiheal (2009) Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (ACTUAL): October 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CLN0021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes