Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques — KR  

Anterior Cruciate Ligament Injury Clinical Trial

Official title: Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study

Status Recruiting

Clinical Trial Summary

Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.

Clinical Trial Description

The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injury

• NCT number: NCT01358656
• Study type: Interventional
• Source: Vita Care
• Contact: Caio O D'Elia, MSc
• Phone: 551131238482
• Email: caio@vita.org.br
• Status: Recruiting
• Phase: N/A
• Start date: January 2010
• Completion date: January 2012