NCT02205645

Initial Safety Evaluation of FibroFix™ Meniscus

A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Orthox Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Detailed description

The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal defect

Conditions

• Other Tear of Medial Meniscus, Current Injury

Interventions

Type	Name	Description
DEVICE	FibroFix™ Meniscus scaffold	The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus. The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2014-07-31
• Last updated: 2019-03-13

Locations

1 site across 1 country: United Kingdom