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Evaluation of the Agili-C Biphasic Implant in the Knee Joint

Primary Purpose

Cartilage Diseases, Osteochondritis Dissecans

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Agili-C Bi-phasic Implant
mini-arthrotomy
Sponsored by
Cartiheal (2009) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cartilage Diseases focused on measuring cartilage, bone

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. 18 to 55 years

  2. Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau

    • Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage.
    • Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters.
  3. Primary or secondary articular cartilage repair.
  4. Knee is stable or can be stabilized as a concomitant procedure.
  5. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
  6. Signed informed consent.
  7. Any misalignments should be fully corrected at the end of the operative procedure.

Exclusion Criteria

  1. Uncorrected axial misalignments >5° that cannot be corrected.
  2. Patellar cartilage defects or pathology.
  3. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
  4. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
  5. Active acute or chronic infection of the treated knee.
  6. Inflammatory arthropathy or crystal-deposition arthropathy.
  7. Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone.
  8. Bony defect depth over 3 millimeters.
  9. Body mass index >35.
  10. Asymptomatic articular cartilage defects.
  11. Bipolar articular cartilage defects.
  12. Osteoarthritis of the operated knee.

  13. Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy.

    • Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months
    • Any previous operation of cartilage treatment within the last 6 months
  14. Patients who are sensitive to materials containing calcium carbonate or hyaluronate
  15. Pregnant women, women who plan to become pregnant and breastfeeding women.
  16. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the patient's welfare.
  17. Substance abuse or alcohol abuse.
  18. Participation in another clinical trials in parallel to this study.
  19. Type I diabetes.
  20. Unable to undergo MRI or X-ray.
  21. Any reasons making the patient a poor candidate in the opinion of the investigator.

Sites / Locations

  • Clinical Hospital ''Sveti Duh''
  • Fakultní nemocnice Brno
  • Uzsoki Street Hospital
  • Rizzoli Orthopaedic Institute
  • Avimed Hospital
  • County Hospital of Timisoara,
  • Institut Za Ortopediju "Banjica"
  • Clinical center of Vojvodina
  • University Medical Centre, Ljubljana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Agili-c bi-phasic implant

Arm Description

mini-arthrotomy

Outcomes

Primary Outcome Measures

improvement in KOOS pain subscales
The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale

Secondary Outcome Measures

KOOS total score
Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales. Change from baseline to 18 and 24 months visit in IKDC current health assessment. Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score. Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000 Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit

Full Information

First Posted
November 10, 2011
Last Updated
August 25, 2021
Sponsor
Cartiheal (2009) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01471236
Brief Title
Evaluation of the Agili-C Biphasic Implant in the Knee Joint
Official Title
Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cartiheal (2009) Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.
Detailed Description
Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Diseases, Osteochondritis Dissecans
Keywords
cartilage, bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agili-c bi-phasic implant
Arm Type
Experimental
Arm Description
mini-arthrotomy
Intervention Type
Device
Intervention Name(s)
Agili-C Bi-phasic Implant
Other Intervention Name(s)
Agili-C implant
Intervention Description
The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone). The implant will be inserted gently in a pressed fit manner.
Intervention Type
Procedure
Intervention Name(s)
mini-arthrotomy
Intervention Description
The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded. Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded.
Primary Outcome Measure Information:
Title
improvement in KOOS pain subscales
Description
The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
Time Frame
24 months
Secondary Outcome Measure Information:
Title
KOOS total score
Description
Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales. Change from baseline to 18 and 24 months visit in IKDC current health assessment. Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score. Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000 Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
number of SAE
Description
Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 18 to 55 years Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage. Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters. Primary or secondary articular cartilage repair. Knee is stable or can be stabilized as a concomitant procedure. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits. Signed informed consent. Any misalignments should be fully corrected at the end of the operative procedure. Exclusion Criteria Uncorrected axial misalignments >5° that cannot be corrected. Patellar cartilage defects or pathology. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present. Active acute or chronic infection of the treated knee. Inflammatory arthropathy or crystal-deposition arthropathy. Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone. Bony defect depth over 3 millimeters. Body mass index >35. Asymptomatic articular cartilage defects. Bipolar articular cartilage defects. Osteoarthritis of the operated knee. Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy. Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months Any previous operation of cartilage treatment within the last 6 months Patients who are sensitive to materials containing calcium carbonate or hyaluronate Pregnant women, women who plan to become pregnant and breastfeeding women. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the patient's welfare. Substance abuse or alcohol abuse. Participation in another clinical trials in parallel to this study. Type I diabetes. Unable to undergo MRI or X-ray. Any reasons making the patient a poor candidate in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizaveta Kon, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital ''Sveti Duh''
City
Zagreb
Country
Croatia
Facility Name
Fakultní nemocnice Brno
City
Brno
Country
Czechia
Facility Name
Uzsoki Street Hospital
City
Budapest
Country
Hungary
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
Country
Italy
Facility Name
Avimed Hospital
City
Katowice
Country
Poland
Facility Name
County Hospital of Timisoara,
City
Timisoara
Country
Romania
Facility Name
Institut Za Ortopediju "Banjica"
City
Belgrade
Country
Serbia
Facility Name
Clinical center of Vojvodina
City
Novi Sad
Country
Serbia
Facility Name
University Medical Centre, Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

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Evaluation of the Agili-C Biphasic Implant in the Knee Joint

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