Tibial Tunnel Placement for ACL Reconstruction

NCT ID: NCT02374710

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

ACL Reconstruction: Anterior Tunnel

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

ACL Reconstruction: Posterior Tunnel

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kentucky

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark D Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Joseph M Hart, Ph.D.

Role: STUDY_DIRECTOR

University of Virginia

Locations

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

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 7584195 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21173195 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23571132 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17922

Identifier Type: -

Identifier Source: org_study_id