Agili-C™ Implant Performance Evaluation

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Ages Eligible for Study:	21 Years to 75 Years (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Adam Waksman	+97298810400	adam@cartiheal.com
Contact: Irit Segalovich	+97298810400	irit@cartiheal.com

Locations

United States, Arizona
Tucson Orthopaedic Institute	Recruiting
Tucson, Arizona, United States, 85712
United States, California
Memorial Orthopaedic Surgical Group	Recruiting
Long Beach, California, United States, 90806
United States, Missouri
University of Missouri	Recruiting
Columbia, Missouri, United States, 65212
United States, New York
NYU Langone Orthopedic Hospital	Recruiting
New York, New York, United States, 10003
United States, Ohio
Ohio State University Wexner Medical Center	Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
Baylor Scott & White Research Institute	Not yet recruiting
Plano, Texas, United States, 75093
Belgium
AZ Monica	Recruiting
Antwerpen, Belgium
France
Clinique St François	Not yet recruiting
Haguenau, France
Israel
Hasharon Hospital, Petach Tikva	Recruiting
Petach Tikva, Israel
Italy
Humanitas Gavazzeni	Recruiting
Bergamo, Italy
Istituto Clinico Humanitas	Recruiting
Rozzano, Italy
Poland
Specialist Hospital. Louis Rydygier in Krakow	Recruiting
Kraków, Poland
Romania
County Hospital Timis Othopedy and Trauma Clinic	Recruiting
Timişoara, Romania
Serbia
Atlas General hospital	Recruiting
Belgrade, Serbia
Clinical Center of Vojvodina	Recruiting
Novi Sad, Serbia
Slovenia
Sanatorij MD Medicina in Ljubljana	Not yet recruiting
Ljubljana, Slovenia

Sponsors and Collaborators

Cartiheal (2009) Ltd

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier:	NCT03299959 History of Changes
Other Study ID Numbers:	CLN0021
First Posted:	October 3, 2017
Last Update Posted:	March 22, 2018
Last Verified:	February 2018

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:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases