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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: <1wk (pre-operative)

Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees

Timeframe: 7-9 months (post-operative)

Trial details

NCT IDNCT03670550

SponsorSteadman Philippon Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04

View on ClinicalTrials.gov More ACL Injury trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.