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Clinical Trials/NCT02374710
NCT02374710
Completed
Not Applicable

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

University of Virginia1 site in 1 country90 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complete Tear, Knee, Anterior Cruciate Ligament
Sponsor
University of Virginia
Enrollment
90
Locations
1
Primary Endpoint
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Status
Completed
Last Updated
11 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2019
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age at time of randomization: 16 - 50 years (skeletally mature)
  • Primary, uncomplicated ACL reconstruction
  • Autograft (STG or BPTB)

Exclusion Criteria

  • Multiple ligament knee injury (full thickness)
  • Revision ACL reconstruction
  • ACL reconstruction with allograft
  • Meniscectomy \> 75%
  • Treatable articular cartilage lesions
  • Diagnosis of tibiofemoral or patellofemoral osteoarthritis (Kellgren Lawrence grade \> II)
  • Valgus alignment on long-leg cassette (weight bearing line outside of joint center)
  • Prior surgery in the ankles, knees, or hips
  • Clinical evidence of hip disease
  • Patellofemoral joint instability

Outcomes

Primary Outcomes

International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation

Time Frame: 24 months

Subjective knee-specific function

Secondary Outcomes

  • Knee Injury Outcome and Osteoarthritis Score (KOOS)(24 months)
  • Visual Analog Scale (VAS)(24 months)
  • Quadriceps Strength(24 months)
  • Gait Analysis(24 months)
  • Knee Arthrometer (KT-1000)(24 months)
  • Marx Activity Rating Scale(24 months)

Study Sites (1)

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