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Procedure

ACL Reconstruction: Anterior Tunnel for Torn Anterior Cruciate Ligament (ACL)

N/A
Waitlist Available
Led By Mark D Miller, M.D.
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.

Eligible Conditions
  • Torn Anterior Cruciate Ligament (ACL)
  • Anterior Cruciate Ligament Tear

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Secondary outcome measures
Gait Analysis
Godin Leisure-Time Questionnaire
Knee Arthrometer (KT-1000)
+7 more
Other outcome measures
Knee Joint Range of Motion
Thigh Circumference
X-Ray (AP, lateral views)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ACL Reconstruction: Anterior TunnelExperimental Treatment1 Intervention
During surgery prior to ACL reconstruction, a line will be measured to indicate 35% of the anterior-to-posterior (front to back) distance of the proximal tibia. The tibial tunnel will be placed anterior (in front) of the 35% line.
Group II: ACL Reconstruction: Posterior TunnelActive Control1 Intervention
During surgery prior to ACL reconstruction, a line will be measured to indicate 35% of the anterior-to-posterior (front to back) distance of the proximal tibia. The tibial tunnel will be placed posterior (in back) of the 35% line.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,244,983 Total Patients Enrolled
University of KentuckyOTHER
186 Previous Clinical Trials
226,594 Total Patients Enrolled
Joseph M Hart, Ph.D.Study DirectorUniversity of Virginia
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

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~9 spots leftby Apr 2025