Tibial Tunnel Placement for ACL Reconstruction

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

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.

Study Overview

• Status: Unknown
• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament; Rupture of Anterior Cruciate Ligament
• Intervention / Treatment: Procedure: ACL Reconstruction: Anterior Tunnel; Procedure: ACL Reconstruction: Posterior Tunnel

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark D Miller, M.D.; Phone Number: 434-243-0278; Email: mdm3p@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Joseph M Hart, Ph.D.; Phone Number: 434-924-6187; Email: jmh3zf@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine
      • Contact: Joseph M Hart, Ph.D.; Phone Number: 434-924-6187; Email: jmh3zf@hscmail.mcc.virginia.edu
      • Contact: Mark D Miller, M.D; Phone Number: 434-243-0278; Email: mdm3p@hscmail.mcc.virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACL Reconstruction: Anterior Tunnel; 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 with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
Active Comparator: ACL Reconstruction: Posterior Tunnel; 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; ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation	Subjective knee-specific function	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury Outcome and Osteoarthritis Score (KOOS)	Subjective knee-specific function	24 months
Marx Activity Rating Scale	Subjective rating of physical activity	24 months
Godin Leisure-Time Questionnaire	Subjective rating of physical activity	24 months
Tegner Activity Rating	Subjective rating of physical activity	24 months
Tampa Scale of Kinesiophobia (TSK)	Subjective fear of movement	24 months
Veterans Rand 12-Item Health Survey (VR-12)	Subjective global health and quality of life	24 months
Visual Analog Scale (VAS)	Subjective pain	24 months
Quadriceps Strength	Thigh muscle strength assessment	24 months
Gait Analysis	Assessment of 3-dimensional movement patterns while walking	24 months
Knee Arthrometer (KT-1000)	Anterior knee laxity	24 months

Other Outcome Measures

Outcome Measure	Time Frame
Knee Joint Range of Motion	24 months
Thigh Circumference	24 months
X-Ray (AP, lateral views)	24 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: University of Kentucky
• Investigators: Principal Investigator: Mark D Miller, M.D., University of Virginia; Study Director: Joseph M Hart, Ph.D., University of Virginia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 17922