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

• ClinicalTrials.gov Identifier: NCT01471236
• Recruitment Status: Completed
• First Posted: November 15, 2011
• Last Update Posted: February 11, 2020
• Sponsor: Cartiheal (2009) Ltd
• Information provided by (Responsible Party): Cartiheal (2009) Ltd

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.

Condition or disease	Intervention/treatment	Phase
Cartilage Diseases; Osteochondritis Dissecans	Device: Agili-C Bi-phasic Implant; Procedure: mini-arthrotomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
• Study Start Date: June 2011
• Actual Primary Completion Date: November 19, 2018
• Actual Study Completion Date: November 19, 2018

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. improvement in KOOS pain subscales [ Time Frame: 24 months ]
   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 :

1. KOOS total score [ Time Frame: 24 months ]
   • 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:

1. number of SAE [ Time Frame: 24 months ]
   Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Croatia

Clinical Hospital ''Sveti Duh''

Zagreb, Croatia

Czechia

Fakultní nemocnice Brno

Brno, Czechia

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

• Responsible Party: Cartiheal (2009) Ltd
• ClinicalTrials.gov Identifier: NCT01471236
• Other Study ID Numbers: CLN0002
• First Posted: November 15, 2011
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

Keywords provided by Cartiheal (2009) Ltd:

cartilage; bone

Additional relevant MeSH terms:

Osteochondritis; Osteochondritis Dissecans; Cartilage Diseases; Bone Diseases; Musculoskeletal Diseases; Connective Tissue Diseases