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Trial record 3 of 3 for:    Agili-C

Agili-C™ Implant Performance Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299959
Recruitment Status : Active, not recruiting
First Posted : October 3, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Cartiheal (2009) Ltd

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE October 3, 2017
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE September 5, 2017
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
KOOS Score [ Time Frame: Preoperative until 2 years postoperatively ]
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03299959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Agili-C™ Implant Performance Evaluation
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Cartilage or Osteochondral Defects in the Knee
  • Up to Moderate Osteoarthritis
Intervention  ICMJE
  • Device: Agili-C implant
    Agili-C implant
  • Procedure: SSOC
    microfracture and/or debridement
Study Arms  ICMJE
  • Experimental: Agili-C
    Intervention: Device: Agili-C implant
  • Active Comparator: Surgical Standard of Care (SSOC)
    Intervention: Procedure: SSOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 9, 2020)
251
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Hungary,   Israel,   Italy,   Poland,   Romania,   Serbia,   United States
Removed Location Countries France,   Slovenia
 
Administrative Information
NCT Number  ICMJE NCT03299959
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Cartiheal (2009) Ltd
Study Sponsor  ICMJE Cartiheal (2009) Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizaveta Kon, MD Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
PRS Account Cartiheal (2009) Ltd
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP