Single- vs. Double-Bundle ACL Reconstruction

NCT01319409 | Completed Phase 2 DMC

• 2 other identifiers: PRO09020493R01AR056630-01A2
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this double-blind, randomized clinical trial to compare outcomes of single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that anatomically reconstructing both bundles of the ACL will lead to better restoration of healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome measures, we will utilize a unique combination of high-speed biplane radiography (for highly accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and cartilage morphology) to characterize joint kinematics and cartilage surface interactions during functional tasks. The specific aims of this study are to: Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal dynamic knee function better than single-bundle ACL reconstruction. Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery. Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as measured with dynamic stereoradiography. Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better clinical outcomes than single-bundle ACL reconstruction. Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical laxity and better range of motion and hop test scores in comparison to single-bundle ACL reconstruction. Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a higher level of activity and more complete return to sport. Successful completion of these aims will provide quantitative evidence of the efficacy of anatomic double-bundle ACL reconstruction for restoring normal knee mechanics. Should the results show a clear benefit for this procedure, it would provide support for wider adaptation of anatomic DB reconstruction. By completing the proposed aims, we will also establish a sound basis for additional studies with longer follow-up (including the subjects in this cohort), to assess the benefits of anatomic DB ACL reconstruction for improving long-term clinical outcomes and maintaining joint and cartilage health.

Conditions

Anterior Cruciate Ligament Injury

Keywords

Anterior cruciate ligament surgery; Anterior cruciate ligament reconstruction; Single bundle anterior cruciate ligament reconstruction; Double bundle anterior cruciate ligament reconstruction; Randomized clinical trial

Outcome Measures

Primary Outcomes (10)

• Side to side difference in peak stance phase knee adduction

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 months after surgery. The side to side difference in peak stance-phase knee adduction was chosen because previous studies have shown that this variable was one that was most different from normal after single-bundle ACL reconstruction.

  6 months

• Side to side difference in peak stance-phase knee external rotation

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 months after surgery. The side to side difference in peak stance-phase knee external rotation was chosen because previous studies have shown that this variable was one that was most different from normal after single-bundle ACL reconstruction.

  6 months

• Side to side difference in peak stance-phase anterior tibial translation

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 months after surgery. The side to side difference in peak stance-phase anterior tibial translation was chosen because it is assumed that one of the primary functions of the ACL is to limit anterior tibial translation.

  6 months

• Relative change in graft elongation from 6 to 24 months

  This is the primary outcome for hypothesis 1.2. Peak stance phase functional graft length will be measured 6 and 24 months after surgery with dynamic stereoradiography during walking and downhill running. For those that underwent double-bundle ACL reconstruction, functional graft length will be determined for both the anteromedial and posterolateral bundles. The relative change in graft elongation will be defined as the increase in peak functional graft length from 6 to 24 months normalized to functional graft length at 6 months.

  Difference from 6 to 24 months

• Pivot shift test

  This is 1 of 2 primary outcomes for hypothesis 2.1, which states that anatomic double-bundle ACL reconstruction will result in more symmetrical laxity and better range of motion and hop test scores in comparison to single-bundle ACL reconstruction 24 months after surgery. The 4-level scale for the pivot shift test will be collapsed to a binary outcome - "normal" vs. "not normal" (nearly normal, abnormal or severely abnormal).

  24 months

• Side to side difference in 30 lb. KT-1000 knee ligament arthrometer

  This is 1 of 2 primary outcomes for hypothesis 2.1, which states that anatomic double-bundle ACL reconstruction will result in more symmetrical laxity and better range of motion and hop test scores in comparison to single-bundle ACL reconstruction 24 months after surgery. The side to side difference for the 30 lb KT-1000 test will be calculated.

  24 months

• IKDC Subjective Knee Form Score

  This is the primary outcome for hypothesis 2.2, which states anatomic double-bundle ACL reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a higher level of activity and more complete return to sports 24 months after surgery. The IKDC Subjective Knee Form is a validated 18-item patient reported measure of symptoms, activity and sports participation for individuals with a variety of knee conditions including ACL injury.

  24 months

• Side to side difference in peak stance phase knee adduction

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery. The side to side difference in peak stance-phase knee adduction was chosen because previous studies have shown that this variable was one that was most different from normal after single-bundle ACL reconstruction.

  24 months

• Side to side difference in peak stance-phase knee external rotation

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery. The side to side difference in peak stance-phase knee external rotation was chosen because previous studies have shown that this variable was one that was most different from normal after single-bundle ACL reconstruction.

  24 months

• Side to side difference in peak stance-phase anterior tibial translation

  This is one of three primary outcomes for hypothesis 1.1 which states that knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery. The side to side difference in peak stance-phase anterior tibial translation was chosen because it is assumed that one of the primary functions of the ACL is to limit anterior tibial translation.

  24 months

Secondary Outcomes (10)

• Joint contact path and velocity

  6 and 24 months

• Cartilage deformation and strain

  6 and 24 months

• Side to side difference in knee range of motion

  3, 6, 12 & 24 months

• Hop tests

  6, 12 & 24 months

• Activities of Daily Living Scale of the Knee Outcome Score

  3, 6, 12, 24 months

Study Arms (2)

Anatomic Double-Bundle ACL Reconstruction

EXPERIMENTAL

Subjects in this arm will undergo anatomic double-bundle ACL reconstruction using an autograft quadriceps tendon with a bone block. The graft will be split into 2 strands, 1 to recreate the posterolateral (PL) bundle, the other to recreate the anteromedial (AM) bundle of the ACL. The bone block will be placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The free ends of the graft will be placed in tunnels located in the centers of the tibial insertions for the PL and AM bundles. The PL bundle will be fixed with the knee in full extension and the AM bundle will be fixed with the knee at 45 degrees of flexion.

Procedure: Anatomic Double-Bundle ACL Reconstruction

Anatomic Single-Bundle ACL Reconstruction

ACTIVE COMPARATOR

Subjects in this arm will undergo anatomic single-bundle ACL reconstruction using an autograft quadriceps tendon with a bone block. The graft will not be split. The bone block will be placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The free end of the graft will be placed in single tunnel located in the center of the tibial ACL insertion site. The graft will be fixed with the knee at 10 20 20 degrees of flexion.

Procedure: Anatomic Single-Bundle ACL Reconstruction

Interventions

Anatomic Double-Bundle ACL Reconstruction PROCEDURE

Surgical reconstruction of the posterolateral (PL) and anteromedial (AM) bundles of the ACL using an autograft quadriceps tendon with a bone block that is split into 2 free arms to recreate the AM and PL bundles. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The free ends of the graft are be placed in 2 separate tunnels located in the centers of the tibial insertions for the PL and AM bundles. The PL bundle is fixed with the knee in full extension and the AM bundle is fixed with the knee at 45 degrees of flexion.

Anatomic Double-Bundle ACL Reconstruction

Anatomic Single-Bundle ACL Reconstruction PROCEDURE

Surgical reconstruction of the ACL using a single autograft quadriceps tendon with a bone block. The free end of the graft is not split. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The single free end of the graft is placed in a single tibial tunnel located in the center of the tibial ACL insertion site. The graft is fixed with the knee in 10 to 20 degrees of flexion.

Anatomic Single-Bundle ACL Reconstruction

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Are between 14 and 50 years of age;
• Are scheduled for ACL reconstruction within 1 year of injury;
• Participate for greater than 100 hours per year in Level I (e.g. football, basketball or soccer) or Level II (e.g. racquet sports, skiing, manual labour occupations) activities;
• Have injury to both bundles of the ACL;
• Have tibial and femoral insertion sites that measure between 14 to 18 mm in diameter, as confirmed at the time of surgery;
• Have a femoral notch that is greater than or equal to 12 mm in width as measured with an arthroscopic ruler at the time of surgery and
• Are willing to continue participation in the study and return for all scheduled follow-up visits, even if he/she moves from the region.

You may not qualify if:

• Had prior surgery of the involved knee;
• Had a prior or currently have injury or surgery to the contra-lateral knee;
• Have open femoral or tibial growth plates as evidenced on the preoperative standard of care radiographs;
• Have greater than a grade I concomitant ligament injury;
• Have an Outerbridge grade 3 or 4 full thickness articular cartilage injury;
• Have evidence on the preoperative clinical MRI of insertional or intratendinous degeneration of the quadriceps tendon;
• Have a quadriceps tendon that is less than 7 mm thick on a sagittal cut of the preoperative clinical MRI;
• Have inflammatory or other forms of arthritis;
• Have any other injury or condition involving the lower extremity that affects the subjects' ability to walk or participate in Level I and II activities.
• Because participation in this study requires subjects to undergo a research-related MRI, subjects will also be excluded if they:
• Had prior surgery for an aneurysm;
• Had any surgery within the past two months;
• Have a cardiac pacemaker;
• Have metal fragments in the eyes, brain or spinal cord;
• Have surgical implants;

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UPMC Center for Sports Medicine

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• James J Irrgang, PT PhD ATC

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Freddie H Fu, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Scott Tashman, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: March 15, 2011
• First Posted: March 21, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)