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NCT Number: NCT02374710

Tibial Tunnel Placement for ACL Reconstruction

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.

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Key information

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Rupture of Anterior Cruciate Ligament Wounds and Injuries

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Significant patellar or tibiofemoral mal-alignment
  • BMI > 35
  • Type 1 Diabetes Mellitus
  • Known connective tissue disorder (e.g. Ehlers-Danlos)
  • Peripheral neuropathy
  • Neurovascular/ circulatory disorder
  • Any form of inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout, lupus, etc.)
  • Significant co-morbid conditions as determined by the investigator (e.g. malignancy, renal, hepatic disease, etc.)
  • Known or suspected psychological disorder

Treatment and study plan

ACL Reconstruction: Anterior Tunnel

Procedure

ACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.

ACL Reconstruction: Posterior Tunnel

Procedure

ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.

Primary outcomes

  1. International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation

    Time frame: 24 months

    Subjective knee-specific function

Secondary outcomes

  1. Knee Injury Outcome and Osteoarthritis Score (KOOS)

    Time frame: 24 months

    Subjective knee-specific function

  2. Marx Activity Rating Scale

    Time frame: 24 months

    Subjective rating of physical activity

  3. Visual Analog Scale (VAS)

    Time frame: 24 months

    Subjective pain

  4. Quadriceps Strength

    Time frame: 24 months

    Thigh muscle strength assessment

  5. Gait Analysis

    Time frame: 24 months

    Assessment of 3-dimensional movement patterns while walking

  6. Knee Arthrometer (KT-1000)

    Time frame: 24 months

    Anterior knee laxity

Other outcomes

  1. Knee Joint Range of Motion

    Time frame: 24 months

    Knee movement measured by goniometer

  2. Thigh Circumference

    Time frame: 24 months

    Measure of your thigh using a tape measure

  3. X-Ray (AP, lateral views)

    Time frame: 24 months

    X-ray of you knee

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • University of Kentucky

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2015
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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