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Agili-C™ Implant Performance Evaluation

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ClinicalTrials.gov Identifier: NCT03299959
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Cartiheal (2009) Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cartilage or Osteochondral Defects in the Knee Up to Moderate Osteoarthritis Device: Agili-C implant Procedure: SSOC Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
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
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. KOOS Score [ Time Frame: Preoperative until 2 years postoperatively ]
    Knee Injury and Osteoarthritis Outcome Score (KOOS)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299959


Contacts
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Contact: Adam Waksman +97298810400 adam@cartiheal.com
Contact: Galit Reske +97298810400 galit@cartiheal.com

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Sponsors and Collaborators
Cartiheal (2009) Ltd
Investigators
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Principal Investigator: Elizaveta Kon, MD Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
More Information
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Responsible Party: Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier: NCT03299959     History of Changes
Other Study ID Numbers: CLN0021
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases