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

NCT01450332 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-10-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tavor Ltd.

    lead INDUSTRY

Principal Investigators

  • Idan M Tobis, B.Sc. · Tavor Ltd.

  • Yoram Litwin, MD · Shaare Zedek Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2013-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450332 on ClinicalTrials.gov