Clinical Screening of Acute Ruptures of the Anterior Cruciate Ligament of the Knee (NCT03113734) | Clinical Trial Compass
UnknownNot Applicable
Clinical Screening of Acute Ruptures of the Anterior Cruciate Ligament of the Knee
France355 participantsStarted 2017-04-29
Plain-language summary
This study develops the construction and validation of a reliable functional screening score in LCA ruptures in the immediate post-traumatic period.
This score, realizable in an emergency, would be an early warning signal requiring an emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA ruptures at a time when ligament testing maneuvers are too painful to be contributory to the diagnosis. It would avoid a premature return to dangerous activity for the knee with a rupture of the LCA.
The other impact would be economical since it would avoid the realization of unnecessary MRI.
On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The hypothesis of the study is that a validated functional score would make it possible to sort the patients in the emergencies and to prescribe the MRI only in the cases of effective rupture of the LCA.
Who can participate
Age range
18 Years – 55 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 of 18 to 55 years,
* Knee trauma occurred less than 9 days prior to hospital emergency visit or medical consultation,
* Absence of bone fractures on the standard radiographic assessment (face and profile),
* Patient affiliated to a social security scheme (beneficiary or beneficiary),
* Patient informed and confirmed his / her agreement to the study.
Exclusion Criteria:
* Severe knee trauma requiring immediate surgical management (fractures, dislocations)
* Traumatic history (including sprain) on the same or other knee
* Impossibility or refusal to do an MRI
* Inability to understand information delivered
* Patient's refusal
* Patients can not be tracked for geographical reasons
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
1
Reference method or "gold standard"
Timeframe: Between 7 days and 2 months after the accident.