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

Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects

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.

Study Overview

• Status: Completed
• Conditions: Cartilage Diseases; Osteochondritis Dissecans
• Intervention / Treatment: Device: Agili-C Bi-phasic Implant; Procedure: mini-arthrotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia
    • Clinical Hospital ''Sveti Duh''
• Czechia
  • Brno, Czechia
    • Fakultní Nemocnice Brno
• Hungary
  • Budapest, Hungary
    • Uzsoki Street Hospital
• Italy
  • Bologna, Italy
    • Rizzoli Orthopaedic Institute
• Poland
  • Katowice, Poland
    • Avimed Hospital
• Romania
  • Timisoara, Romania
    • County Hospital of Timisoara,
• Serbia
  • Belgrade, Serbia
    • Institut Za Ortopediju "Banjica"
  • Novi Sad, Serbia
    • Clinical Center of Vojvodina
• Slovenia
  • Ljubljana, Slovenia
    • University Medical Centre, Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Agili-c bi-phasic implant; mini-arthrotomy

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 Names: Agili-C implant; Procedure: mini-arthrotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of SAE	Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions	24 months

Collaborators and Investigators

• Sponsor: Cartiheal (2009) Ltd
• Investigators: Principal Investigator: Elizaveta Kon, MD

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 19, 2018
• Study Completion (Actual): November 19, 2018

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cartilage; bone
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: CLN0002