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Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

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: NCT02423629
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Cartiheal (2009) Ltd

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE April 22, 2015
Last Update Posted Date February 11, 2020
Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
• The KOOS Pain Subscale relative to baseline [ Time Frame: 24 Months ]
The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2015)
• Improvement in KOOS Pain Subscale. [ Time Frame: 24 Months ]
The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2016)
  • • Improvement in other KOOS subscales relative to baseline [ Time Frame: 24 Months ]
    Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m • •
  • • Improvement in IKDC Subjective Knee Score relative to baseline [ Time Frame: 24 Months ]
    IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in SF-36 Survey [ Time Frame: 24 Months ]
    SF-36 Survey is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in Tegner Score [ Time Frame: 24 Months ]
    Tegner Score is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in Lysholm Knee Scoring Scale [ Time Frame: 24 Months ]
    Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m
  • • Joint Space maintenance rate according to X-ray [ Time Frame: 24 Months ]
    Joint Space maintenance rate is evaluated at 12m & 24m
  • • Defect Fill according to MRI [ Time Frame: 24 Months ]
    Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m
  • Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline [ Time Frame: 24 mMonths ]
    The KOOS Overall is evaluated at 6, 12,18 and 24 months
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2015)
  • Improvement in KOOS Score and Subscales [ Time Frame: 24 Months ]
    • Improvement in KOOS Score and Subscales.
  • Improvement in IKDC Subjective Knee Score (and VAS as part of it) . [ Time Frame: 24 Months ]
    Improvement in IKDC Subjective Knee Score (and VAS as part of it) .
  • Improvement in IKDC Knee Examination Form - 2000 [ Time Frame: 24 Months ]
    Improvement in IKDC Knee Examination Form - 2000
  • Improvement in the SF-36 Questionnaire. [ Time Frame: 24 Months ]
    Improvement in the SF-36 Questionnaire.
  • Improvement in Tegner Score. [ Time Frame: 24 Months ]
    Improvement in Tegner Score.
  • Improvement in Lysholm Knee Scoring Scale. [ Time Frame: 24 Months ]
    Improvement in Lysholm Knee Scoring Scale.
  • Improvement in MOCART Scoring [ Time Frame: 24 Months ]
    Improvement in MOCART Scoring
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 in the Repair of Cartilage and Osteochondral Defects
Official Title  ICMJE Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
Brief Summary Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Detailed Description

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cartilage or Osteochondral Defects in the Knee
Intervention  ICMJE Device: Agili-C™ implantation procedure
Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.
Study Arms  ICMJE Agili C™
Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.
Intervention: Device: Agili-C™ implantation procedure
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2016)
150
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2015)
50
Actual Study Completion Date  ICMJE November 19, 2019
Actual Primary Completion Date November 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years or older
  2. Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
  3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
  4. KOOS Pain score at baseline is not less than 30 and not more than 65
  5. Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
  6. Informed consent signing

Exclusion Criteria:

  1. Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
  2. Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
  3. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
  4. Lack of functional remaining meniscus
  5. Meniscal transplantation in the past 6 months
  6. Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
  7. Any known tumor of the index knee
  8. Any know history of infection of the index knee
  9. Any known history of inflammatory arthropathy or crystal-deposition arthropathy
  10. Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
  11. Body mass index >35
  12. Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
  13. Chemotherapy treatment in the past 12 months
  14. Any previous surgical cartilage treatment in the index knee within the last 6 months
  15. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
  16. Patient who is pregnant or intends to become pregnant during the study
  17. History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
  18. Known substance abuse or alcohol abuse
  19. Participation in other clinical trials within 30 days prior to the study or concurrent with the study
  20. Known insulin dependent diabetes mellitus
  21. Unable to undergo MRI or X-ray
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02423629
Other Study ID Numbers  ICMJE CLN0019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 Rizzoli Institute, Bologna , Italy
PRS Account Cartiheal (2009) Ltd
Verification Date October 2019

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