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Evaluation of the Agili-C Biphasic Implant in the Knee Joint | Clinical Trials | Clareo Health

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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

NCT01471236•Smith & Nephew, Inc.

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.

Eligibility

Age

18 - 55 years

Sex

ALL

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.
+13 more criteria

Locations (9)

Clinical Hospital ''Sveti Duh''

Zagreb, Croatia

Fakultní nemocnice Brno

Brno, Czechia

Uzsoki Street Hospital

Budapest, Hungary

Rizzoli Orthopaedic Institute

Bologna, Italy

Avimed Hospital

Katowice, Poland

County Hospital of Timisoara,

Timișoara, Romania

Institut Za Ortopediju "Banjica"

Belgrade, Serbia

Clinical center of Vojvodina

Novi Sad, Serbia

University Medical Centre, Ljubljana

Ljubljana, Slovenia

Key Dates

Start Date

June 1, 2011

Primary Completion Date

November 19, 2018

Completion Date

November 19, 2018

Last Updated

March 6, 2025

Enrollment

ACTUAL participants

Conditions

Cartilage DiseasesOsteochondritis Dissecans

Interventions

Agili-C Bi-phasic Implant

DEVICE

mini-arthrotomy

PROCEDURE

Psychological Response and Readiness Associated With OCD of the Knee

NCT04649905

Osteochondritis Dissecans KneePsychological Stress

View study

RECRUITING

Knee Registry (Knieregister)

NCT04364334

Knee PathologyOsteoarthritis, Knee+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Psychological Response and Readiness Associated With OCD of the Knee

Knee Registry (Knieregister)

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