Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes (NCT03190889) | Clinical Trial Compass
CompletedNot Applicable
Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
United States150 participantsStarted 2018-08-01
Plain-language summary
The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL) injury in vulnerable populations (active athletes between 14 = 24 years old) through the identification of relative injury risk groups based on subject-specific movement patterns prior to second injury, as well as through the determination of effect for differential rehabilitation protocols following initial ACL reconstruction and prior to return to sport. As nearly one-third of athletes who have a primary ACL injury and return to sport will experience a secondary injury, results from the proposed work will allow us to prospectively identify high risk patients who are the most appropriate recipients of enhanced treatment, including targeted training, which may reduce the risk of second ACL injury. Secondary ACL injury has the potential to end athletic careers, promote the development of osteoarthritis, and have debilitating effects on quality of life. Hence, the information gathered in this investigation will offer ACL injured athletes the optimal potential to reduce or potentially prevent these negative health effects before they are initiated.
Who can participate
Age range
13 Years – 30 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:
* Age, 13 ≥ 30 years
* Acute (\< 6 months), first-time, isolated ACL injury
* No history of previous knee surgery to either extremity
* No low back or lower extremity injury in the year prior to ACL injury necessitating medical care
* Pre-injury participation in cutting, jumping or pivoting sports for ≥ 50 hours/year
* Mechanism of injury did not involve a direct blow to the knee.
* Patients who sustain a medial collateral ligament (MCL) injury are eligible for study participation if medial knee instability is resolved prior to surgery
* Patients with simple meniscus tears (i.e., 2 cm vertical longitudinal tear) that do not necessitate alterations in rehabilitation will be eligible for study participation
Exclusion Criteria:
* History of previous knee surgery to either extremity
* Low back or lower extremity injury in the year prior to ACL injury necessitating medical care
* Second or greater ACL injury
* Greater than 6 months since occurrence of ACL injury
* Lack of participation in cutting, jumping, or pivoting sport
* Mechanisms of injury involved a direct blow of force to the knee
* Patients with MCL injury that exhibits unresolved medial knee instability
* Patients with complex, repairable meniscus tears (i.e., radial or root repair) and patients with full thickness articular cartilage lesions will not be eligible for participation secondary to significant alterations to postoperative rehabilitation protocol
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.