Dynamic ACL Brace: In Vivo Kinematics



Status:Withdrawn
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 60
Updated:2/17/2019
Start Date:October 2018
End Date:December 2019

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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.


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.
We found this trial at
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Vail, CO
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