Dynamic ACL Brace: In Vivo Kinematics (NCT03670550) | Clinical Trial Compass
WithdrawnNot Applicable
Dynamic ACL Brace: In Vivo Kinematics
Stopped: Attending surgeon on the project is moving to a different facility
United States0Started 2018-10-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sen…
What they're measuring
1
Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees
Timeframe: <1wk (pre-operative)
2
Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees