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Clinical Trials/NCT02913404
NCT02913404CompletedNot Applicable

Functional Biomechanical Outcome of ACL-reconstruction vs. ACL-reconstruction and Extra-articular-tenodesis in Patients

University of Pittsburgh2 sites in 1 country20 target enrollmentStarted: January 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change in KOOS

Study Overview

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).

Detailed Description

Screening Protocol All participants that express interest in the study will receive a screening interview that will determine eligibility for participation in the study. The screening of surgical patients will be performed by one of the clinical research coordinators in the clinic of Dr. Musahl.

Potential participants who pass the screening interview will be provided a copy of the informed consent form (in person or via email). The potential participant will review the consent form in detail with a member of the clinical team in order to ensure that the participant understands the information contained in the consent form and to provide an opportunity for the participant to ask questions about the study. If the potential participant then agrees to participate, the consent form will be signed by the participant and a member of the clinical team.

Surgical Protocol Baseline testing before surgery will consist of the IKDC objective and subjective score, KOOS score, Marx activity level, Lysohm Scale and VR-12. A radiologist will grade clinical MRI for ACL, meniscus, MCL, LCL, and ALC injury. Quantitative pivot shift testing will be performed under anesthesia using the PIVOT technology and inertial sensor. Intraoperative grading of ACL injury and concomitant injuries to the articular cartilage and meniscus will be performed. If deemed eligible final randomization will occur following intraoperative grading.

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.

Research Scans After surgery, approximately 6 months, subjects will undergo a CT scan on bilateral knees. The CT scan will be used to create volumetric models. These bone models will be matched to the dynamic biplane x-rays. Subjects will also undergo a research MRI scan on bilateral knees. The MRI scan will be used to generate models of the knee articular cartilage.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
14 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

Demographic Questionnaire

Time Frame: Visit 1 (up to two weeks prior to surgery)

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

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Anderst

Principal Investigator

University of Pittsburgh

Study Sites (2)

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