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ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Knee Injuries Clinical Trial

Official title:
Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Clinical Trial Summary

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

Clinical Trial Description

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.

Primary outcome is graft ligamentization assessed in MRI images at 4-6 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04550299
Study type Interventional
Source Vita Care
Contact Instituto Vita
Email institutovita@institutovita.org.br
Status Recruiting
Phase N/A
Start date February 26, 2013
Completion date December 1, 2023
View Details
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