NCT01471236

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cartilage Diseases
• Osteochondritis Dissecans

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2011-11-15
• Last updated: 2025-03-06

Locations

9 sites across 8 countries: Croatia, Czechia, Hungary, Italy, Poland, Romania, Serbia, Slovenia