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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier:
NCT01471236
First received: November 10, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Cartilage Diseases
Osteochondritis Dissecans
Device: Agili-C Bi-phasic Implant
Procedure: mini-arthrotomy or arthroscopy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects

Resource links provided by NLM:


Further study details as provided by Cartiheal (2009) Ltd:

Primary Outcome Measures:
  • improvement in KOOS pain subscales [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • 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


Other Outcome Measures:
  • number of SAE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions


Enrollment: 65
Study Start Date: June 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Agili-c bi-phasic implant
mini-arthrotomy or arthroscopy
Device: Agili-C Bi-phasic Implant

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.

Other Name: Agili-C implant
Procedure: mini-arthrotomy or arthroscopy

The procedure will be conducted according to hospital practice. The implants will be positioned via arthroscopy or 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471236

Locations
Croatia
Clinical Hospital ''Sveti Duh''
Zagreb, Croatia
Czech Republic
Fakultní nemocnice Brno
Brno, Czech Republic
Hungary
Uzsoki Street Hospital
Budapest, Hungary
Italy
Rizzoli Orthopaedic Institute
Bologna, Italy
Romania
County Hospital of Timisoara,
Timisoara, Romania, 300203
Serbia
Institut za Ortopedsko-hirurške
Belgrade, Serbia
Clinical center of Vojvodina
Novi Sad, Serbia
Sponsors and Collaborators
Cartiheal (2009) Ltd
Investigators
Principal Investigator: Elizaveta Kon, MD
  More Information

No publications provided

Responsible Party: Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier: NCT01471236     History of Changes
Other Study ID Numbers: CLN0002
Study First Received: November 10, 2011
Last Updated: February 13, 2014
Health Authority: Slovenia: Ethics Committee
Hungary: Institutional Ethics Committee
Austria: Ethikkommission
Poland: Ethics Committee
Serbia: Ethics Committee
Czech Republic: Ethics Committee
Romania: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Croatia: Ethics Committee
Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by Cartiheal (2009) Ltd:
cartilage
bone

Additional relevant MeSH terms:
Cartilage Diseases
Osteochondritis
Osteochondritis Dissecans
Bone Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014