Tibial Tunnel Placement for ACL Reconstruction

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title: Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial

Status Recruiting

Clinical Trial Summary

Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral tunnel placement, very little attention has been given to the tibial tunnel. Researchers have suggested that the tibial tunnel be placed in the center of the ACL footprint, which they described as being approximately 43% of the way (anterior-to-posterior) across the proximal tibia at its widest extent. However, others have suggested that a more anterior placement may yield improved biomechanical and clinical results. The center of the ACL footprint and the posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel placement a consistent percentage of the way across the tibial plateau; therefore, guidelines should be based on intraoperative fluoroscopic measurements. However, the question remaining is what percentage of the anterior-to-posterior distance across the tibia is the ideal location for the tibial tunnel in ACL reconstruction. This study will help answer that question.

Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction will be considered for enrollment. Eligible patients will be allocated to one of two groups based on the location of the tibial tunnel (anterior vs. posterior) during the surgical procedure. In addition to a baseline (pre-operative) evaluation, participants will return for follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24 months.

The primary objective of this study is to collect subjective and objective measures of knee-related function in patients with an anterior vs. posterior placed tibial tunnel through 24 months postoperative care.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament
• Rupture of Anterior Cruciate Ligament

• NCT number: NCT02374710
• Study type: Interventional
• Source: University of Virginia
• Contact: Mark D Miller, M.D.
• Phone: 434-243-0278
• Email: mdm3p@hscmail.mcc.virginia.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Completion date: April 2019