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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

Brief Summary:
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Condition or disease Intervention/treatment Phase
Cartilage or Osteochondral Defects in the Knee Device: Agili-C™ implantation procedure Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
Study Start Date : May 2014
Actual Primary Completion Date : November 19, 2019
Actual Study Completion Date : November 19, 2019

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. • The KOOS Pain Subscale relative to baseline [ Time Frame: 24 Months ]
    The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m


Secondary Outcome Measures :
  1. • Improvement in other KOOS subscales relative to baseline [ Time Frame: 24 Months ]

    Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m •


  2. • Improvement in IKDC Subjective Knee Score relative to baseline [ Time Frame: 24 Months ]
    IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m

  3. • Improvement in SF-36 Survey [ Time Frame: 24 Months ]
    SF-36 Survey is evaluated at 6m, 12m, 18m & 24m

  4. • Improvement in Tegner Score [ Time Frame: 24 Months ]
    Tegner Score is evaluated at 6m, 12m, 18m & 24m

  5. • Improvement in Lysholm Knee Scoring Scale [ Time Frame: 24 Months ]
    Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m

  6. • Joint Space maintenance rate according to X-ray [ Time Frame: 24 Months ]
    Joint Space maintenance rate is evaluated at 12m & 24m

  7. • Defect Fill according to MRI [ Time Frame: 24 Months ]
    Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02423629


Locations
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Italy
Rizzoli Orthopaedic Institute
Bologna, Italy
Sponsors and Collaborators
Cartiheal (2009) Ltd
Investigators
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Principal Investigator: Elizaveta Kon, MD Rizzoli Institute, Bologna , Italy
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Responsible Party: Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier: NCT02423629    
Other Study ID Numbers: CLN0019
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: October 2019
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases