Tibial Tunnel Placement for ACL Reconstruction

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02374710
• Other study ID #: 17922
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2015
• Last updated: April 16, 2015
• Start date: April 2015
• Est. completion date: April 2019

Study information

• Verified date: April 2015
• Source: University of Virginia
• Contact: Mark D Miller, M.D.
• Phone: 434-243-0278
• Email: mdm3p[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament
• Rupture of Anterior Cruciate Ligament

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (3)

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):3 — View 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. Ep — View Citation

Stäubli 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee Joint Range of Motion		24 months	No
Other	Thigh Circumference		24 months	No
Other	X-Ray (AP, lateral views)		24 months	No
Primary	International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation	Subjective knee-specific function	24 months	No
Secondary	Knee Injury Outcome and Osteoarthritis Score (KOOS)	Subjective knee-specific function	24 months	No
Secondary	Marx Activity Rating Scale	Subjective rating of physical activity	24 months	No
Secondary	Godin Leisure-Time Questionnaire	Subjective rating of physical activity	24 months	No
Secondary	Tegner Activity Rating	Subjective rating of physical activity	24 months	No
Secondary	Tampa Scale of Kinesiophobia (TSK)	Subjective fear of movement	24 months	No
Secondary	Veterans Rand 12-Item Health Survey (VR-12)	Subjective global health and quality of life	24 months	No
Secondary	Visual Analog Scale (VAS)	Subjective pain	24 months	No
Secondary	Quadriceps Strength	Thigh muscle strength assessment	24 months	No
Secondary	Gait Analysis	Assessment of 3-dimensional movement patterns while walking	24 months	No
Secondary	Knee Arthrometer (KT-1000)	Anterior knee laxity	24 months	No