Dynamic ACL Brace: In Vivo Kinematics

Brief Title

Dynamic ACL Brace: In Vivo Kinematics

Official Title

Dynamic ACL Brace: In Vivo Kinematics

Brief Summary

      The purpose of this study is to evaluate the effect of the Össur Rebound dynamic ACL brace on
      knee kinematics evaluated using dynamic stereo X-ray (DSX) imaging during functional
      activities. Brace performance will be evaluated before and after ACL reconstruction.
    



Study Type

Interventional


Primary Outcome

Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees

Secondary Outcome

 Percent symmetry in 3D motion capture kinematics and kinetics

Condition

ACL Injury

Intervention

Ossur Rebound ACL Brace

Study Arms / Comparison Groups

 Knee Brace
Description:  ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy.
Dynamic X-ray imaging of the knee will take place prior to surgery, and again upon clearance from physical therapy 7-9 months after surgery. The injured knee will be imaged with and without the brace, and the contralateral limb will be imaged for use as a control.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

October 2018

Completion Date

December 2019

Primary Completion Date

April 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Unilateral, complete ACL (Anterior Cruciate Ligament) ruptures (must be documented by
             prior MRI)

          -  No other concomitant lower extremity injuries and an uninjured contralateral limb

          -  Acute ACL tears that will be scheduled for ACL reconstruction with Dr. Robert F.
             LaPrade

          -  Minimal swelling and pain

          -  Able and willing to perform the required study activities

        Exclusion Criteria:

          -  Previous surgery or significant injury to either knee

          -  Relevant surgery, procedure, injury, or condition in the past two years which may
             affect knee pain or general movement patterns on either side

          -  Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which
             may affect musculoskeletal health

          -  Women who are pregnant, or trying/planning to become pregnant during the next 10
             months

          -  Known balance or vestibular disorders

          -  Persons with a history of significant radiation exposure, whether occupational or
             medical in nature (Anyone with a history of medical radiation therapy, for cancer or
             other conditions, is excluded from the study. Those who have an annual occupational
             radiation exposure greater than 25mSv may not enroll.)

          -  Persons with a pacemaker, hearing aid, aneurysm clip or artificial heart valve, or
             other forms of loose metal implants

          -  Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care
             at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury,
             significant meniscal damage

          -  Allergy or sensitivity to silver or latex

          -  Adults lacking capacity to consent for themselves

        Post-Op Visit Exclusion Criteria

          -  Participants who do not pass their return-to-sport test within 7-9 months of
             ACL-Reconstruction surgery will be excluded from the second phase of testing.

          -  Participants who no longer pass the MRI screening at the time of Phase 2 testing (for
             example, who have a new loose metal implant), will be excluded from the MRI portion of
             the testing only.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03670550

Organization ID

2018-31


Responsible Party

Sponsor

Study Sponsor

Steadman Philippon Research Institute

Collaborators

 Össur Ehf

Study Sponsor

, , 


Verification Date

February 2019