NCT02913404

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

September 16, 2016

Last Update Submit

October 5, 2020

Conditions

ACL

Outcome Measures

Primary Outcomes (8)

  • Change of joint kinematics

    Outcome data includes: Joint contact path, functional joint space, anterior translation, varus-valgus rotation, and internal-external rotation will be obtained.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

  • Change in IKDC subjective

    The international knee documentation committee's objective scale will be used to record the surgical procedure on the knee.

    Surgical Visit

  • Demographic Questionnaire

    This will include race, age, sex, height and weight.

    Visit 1 (up to two weeks prior to surgery)

  • Change in KOOS

    The knee injury and Osteoarthritis Outcome Score is used to access the subjects view on the knee injury.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

  • Change in VAS

    This visual scale will be used by the subject to report the level of pain at the time of testing.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

  • Change in Marx Activity Scale

    This scale will be used by the subject to report level of activity in the past year.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

  • Change in Lysohm Scale

    This scale will be used by the subject to report how the knee problems have affected management of daily life.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

  • Change in VR-12

    This scale will be used by the subject to measure health related to quality of life.

    Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

Study Arms (2)

ACL Reconstruction

EXPERIMENTAL

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

ACL Recon. extra-articular-tenodesis

EXPERIMENTAL

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

Interventions

ACL ReconstructionPROCEDURE

standard surgical procedure

ACL Reconstruction
ACL Recon. extra-articular-tenodesisPROCEDURE

standard surgical procedure and extra-articular-tenodesis will be used for a randomized portion of participants

ACL Recon. extra-articular-tenodesis

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between age of 14-40
  • BMI between 18-35
  • have a contralateral healthy knee and within 12 months of grade 3 injury to the ipsilateral ACL
  • no greater than grade 2 injury to MCL or LCL and absence of PCL injury
  • articular cartilage injury grade 2 or lower
  • 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
  • Use of a quad tendon graft or BTB graft

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Biodynamics Lab

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (2)

  • Chiba D, Gale T, Nishida K, Suntaxi F, Lesniak BP, Fu FH, Anderst W, Musahl V. Lateral Extra-articular Tenodesis Contributes Little to Change In Vivo Kinematics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2021 Jun;49(7):1803-1812. doi: 10.1177/03635465211003298. Epub 2021 Apr 19.

    PMID: 33872056DERIVED

  • Nishida K, Gale T, Chiba D, Suntaxi F, Lesniak B, Fu F, Anderst W, Musahl V. The effect of lateral extra-articular tenodesis on in vivo cartilage contact in combined anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2022 Jan;30(1):61-70. doi: 10.1007/s00167-021-06480-4. Epub 2021 Feb 12.

    PMID: 33580345DERIVED

Study Officials

  • William Anderst, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 23, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)