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ACL-reconstruction vs ACL-reconstruction With EAT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913404
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
William Anderst, University of Pittsburgh

Brief Summary:
The purpose of this study is to asses functional biomechanical outcomes and patient reported outcome measures following single bundle ACL reconstruction (ACL-R) compared to single bundle ACL reconstruction and extra articular tenodesis (ACL-R+EAT).

Condition or disease Intervention/treatment Phase
ACL Procedure: ACL Reconstruction Procedure: ACL Recon. extra-articular-tenodesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Functional Biomechanical Outcome of ACL-reconstruction vs. ACL-reconstruction and Extra-articular-tenodesis in Patients
Study Start Date : January 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACL Reconstruction

Surgical Protocol

Standard single bundle anatomic ACL reconstruction will be performed for all subjects. Quadrupled hamstring tendon will be used with cortical fixation on femur and tibia.

Procedure: ACL Reconstruction
standard surgical procedure

Experimental: ACL Recon. extra-articular-tenodesis

Surgical Protocol

Standard single bundle anatomic ACL reconstruction will be performed for all subjects. Quadrupled hamstring tendon will be used with cortical fixation on femur and tibia. ACL-R+EAT will be performed as described by Marcacci with doubled hamstring tendon left attached at the pes anserinus, an anatomic tibial tunnel, staple fixation in the over the top position, routing of the graft superficial to the LCL, and staple fixation at Gerdy's tubercle. Concomitant tears to the menisci and their roots will be repaired as indicated.

Procedure: ACL Recon. extra-articular-tenodesis
standard surgical procedure and extra-articular-tenodesis will be used for a randomized portion of participants




Primary Outcome Measures :
  1. Change of joint kinematics [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    Outcome data includes: Joint contact path, functional joint space, anterior translation, varus-valgus rotation, and internal-external rotation will be obtained.

  2. Change in IKDC subjective [ Time Frame: Surgical Visit ]
    The international knee documentation committee's objective scale will be used to record the surgical procedure on the knee.

  3. Demographic Questionnaire [ Time Frame: Visit 1 (up to two weeks prior to surgery) ]
    This will include race, age, sex, height and weight.

  4. Change in KOOS [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    The knee injury and Osteoarthritis Outcome Score is used to access the subjects view on the knee injury.

  5. Change in VAS [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    This visual scale will be used by the subject to report the level of pain at the time of testing.

  6. Change in Marx Activity Scale [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    This scale will be used by the subject to report level of activity in the past year.

  7. Change in Lysohm Scale [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    This scale will be used by the subject to report how the knee problems have affected management of daily life.

  8. Change in VR-12 [ Time Frame: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery) ]
    This scale will be used by the subject to measure health related to quality of life.



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. between age of 14-40
  2. BMI between 18-35
  3. have a contralateral healthy knee and within 12 months of grade 3 injury to the ipsilateral ACL
  4. no greater than grade 2 injury to MCL or LCL and absence of PCL injury
  5. articular cartilage injury grade 2 or lower
  6. display a quantitative pivot shift test of >=3 mm lateral translation or >8 m/sec*2, or a side to side difference of 50% or greater
  7. Use of a quad tendon graft or BTB graft

EXCLUSION CRITERIA:

  • Subjects will have no other injury or disease that will interfere with knee function. Subjects will be of generally good health and will have decided to undergo ACL reconstruction surgery and agreed to participate in the study (following informed consent procedures).
  • Potential candidates who do not intend to stay in the Pittsburgh area for a period of at least a year following surgery will be excluded.
  • Pregnant females will be excluded. Urine pregnancy tests will be administered by the PI prior to research-related exposure to radiation (CT scan, Biodynamics Lab testing). If these radiation exposures occur on the same date, only one pregnancy test will be administered. If these radiation exposures occur on different dates, a pregnancy test will be administered each date.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913404


Locations
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United States, Pennsylvania
University of Pittsburgh Biodynamics Lab
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: William Anderst, PhD University of Pittsburgh
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Responsible Party: William Anderst, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02913404    
Other Study ID Numbers: PRO16080675
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No