NCT01450332

Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis

A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tavor Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	Knee-T-Nol	The ACL prosthesis is intended for the treatment of ruptured ACL. It will be used as an implant to replace the native, torn ACL. Implantation will be done using arthroscopy

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2011-10-12
• Last updated: 2011-10-12

Locations

1 site across 1 country: Israel