Clinical trial NCT02374710: Tibial Tunnel Placement for ACL Reconstruction
Official title: Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
Rupture of Anterior Cruciate Ligament
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2015-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
timeFrame: 24 months
Secondary outcomes:
measure: Knee Injury Outcome and Osteoarthritis Score (KOOS)
timeFrame: 24 months
measure: Marx Activity Rating Scale
timeFrame: 24 months
measure: Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Quadriceps Strength
timeFrame: 24 months
measure: Gait Analysis
timeFrame: 24 months
measure: Knee Arthrometer (KT-1000)
timeFrame: 24 months
Other outcomes:
measure: Knee Joint Range of Motion
timeFrame: 24 months
measure: Thigh Circumference
timeFrame: 24 months
measure: X-Ray (AP, lateral views)
timeFrame: 24 months
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine
state: Virginia
Study officials:
affiliation: University of Virginia
name: Mark D Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Joseph M Hart, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.