NCT02423629

Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Detailed description

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects. The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant

Conditions

• Cartilage or Osteochondral Defects in the Knee

Interventions

Type	Name	Description
DEVICE	Agili-C™ implantation procedure	Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-11-19
• Completion: 2019-11-19
• First posted: 2015-04-22
• Last updated: 2025-03-06

Locations

8 sites across 8 countries: Austria, Belgium, Israel, Italy, Poland, Romania, Serbia, Slovenia