NCT02374710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

February 18, 2015

Last Update Submit

May 7, 2025

Conditions

Complete Tear, Knee, Anterior Cruciate LigamentRupture of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation

    Subjective knee-specific function

    24 months

Secondary Outcomes (6)

  • Knee Injury Outcome and Osteoarthritis Score (KOOS)

    24 months

  • Marx Activity Rating Scale

    24 months

  • Visual Analog Scale (VAS)

    24 months

  • Quadriceps Strength

    24 months

  • Gait Analysis

    24 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Knee Joint Range of Motion

    24 months

  • Thigh Circumference

    24 months

  • X-Ray (AP, lateral views)

    24 months

Study Arms (2)

ACL Reconstruction: Anterior Tunnel

EXPERIMENTAL

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.

Procedure: ACL Reconstruction: Anterior Tunnel

ACL Reconstruction: Posterior Tunnel

ACTIVE COMPARATOR

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.

Procedure: ACL Reconstruction: Posterior Tunnel

Interventions

ACL Reconstruction: Anterior TunnelPROCEDURE

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: Anterior Tunnel
ACL Reconstruction: Posterior TunnelPROCEDURE

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

ACL Reconstruction: Posterior Tunnel

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Charlottesville, Virginia, 22903, United States

Location

Related Publications (3)

  • Staubli HU, Rauschning W. Tibial attachment area of the anterior cruciate ligament in the extended knee position. Anatomy and cryosections in vitro complemented by magnetic resonance arthrography in vivo. Knee Surg Sports Traumatol Arthrosc. 1994;2(3):138-46. doi: 10.1007/BF01467915.

    PMID: 7584195RESULT

  • Bedi A, Maak T, Musahl V, Citak M, O'Loughlin PF, Choi D, Pearle AD. Effect of tibial tunnel position on stability of the knee after anterior cruciate ligament reconstruction: is the tibial tunnel position most important? Am J Sports Med. 2011 Feb;39(2):366-73. doi: 10.1177/0363546510388157. Epub 2010 Dec 20.

    PMID: 21173195RESULT

  • Hatayama K, Terauchi M, Saito K, Higuchi H, Yanagisawa S, Takagishi K. The importance of tibial tunnel placement in anatomic double-bundle anterior cruciate ligament reconstruction. Arthroscopy. 2013 Jun;29(6):1072-8. doi: 10.1016/j.arthro.2013.02.003. Epub 2013 Apr 6.

    PMID: 23571132RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Mark D Miller, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Joseph M Hart, Ph.D.

    University of Virginia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 2, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(1)