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
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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
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Verification Date
February 2019