Dynamic ACL Brace: In Vivo Kinematics
Withdrawn before enrolling · Not applicable
Conditions studied: ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL, ACL - Anterior Cruciate Ligament Deficiency
In brief
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.
Key facts
- Study ID
- NCT03670550
- Run by
- Steadman Philippon Research Institute
- People needed
- 0
- Starts
- 2018-10-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Steadman Philippon Research Institute — Vail, Colorado, United States
Full record on ClinicalTrials.gov
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