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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-11-19

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Cartilage Diseases Osteochondritis Dissecans

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Agili-c bi-phasic implant

mini-arthrotomy

Group Type EXPERIMENTAL

Agili-C Bi-phasic Implant

Intervention Type DEVICE

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.

mini-arthrotomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Agili-C implant

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No