NCT02831244

Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

Detailed description

Agili-C™ implant is a CE marked. The Agili-CTM implant is a 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

• Osteoarthritis of Multiple Joints of Ankle or Foot

Interventions

Type	Name	Description
DEVICE	Agili-CTM	Consenting individuals will be selected from the population of patients with osteoarthritis of the great toe examined by a participating investigator. Following signing an informed consent, candidates will be evaluated by an adjudication committee for possible inclusion in the trial based on medical history and Standing Foot X-ray. Candidates that are approved or conditionally approved by the adjudication committee will undergo Agili-CTM implantation procedure

Timeline

• Start date: 2016-08-10
• Primary completion: 2019-06-23
• Completion: 2019-06-23
• First posted: 2016-07-13
• Last updated: 2025-03-06

Locations

4 sites across 4 countries: Israel, Italy, Serbia, Slovenia