Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT01508728
Eligibility Criteria:
Inclusion Criteria:
* Patients agreeing to participate in the study and who signed informed consent.
* Indication of bracing immobilization for 6 weeks following a unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and a peripheral injury, medial or lateral collateral ligament, with or without meniscal lesion.
* MRI scan confirming the nature of the lesion to be provided
during the inclusion visit.
* Patients whose knee is immobilized for 7 to 15 days in Zimmer-like splint.
* Patients aged from 18 to 65.
* Patients agreeing to choose their physiotherapist from a list provided by the investigators.
* Patient (s) with insurance coverage.
Exclusion Criteria:
* Patients with a bucket handle meniscus tear.
* Patients with a pentad injury.
* Patients with osteochondral fragments.
* Patients with a knee fracture apart from "Segond fracture" and "bone bruise".
* Patients who underwent ligament surgery for the concerned knee.
* Patients with a bone lesion which may interfere with the knee joint(distal femur, proximal tibia, patella).
* Patients with any history of rupture of the central pivot (anterior cruciate ligament and posterior cruciate ligament), of lateral ligament planes rupture (medial collateral ligament and lateral collateral) or lateral planes ligament injury without rupture, dating from less than 1 year.
* Patients whose sprain results from an accident at work.
* Patients with an inability / unwillingness to follow protocol requirements.
* Patients for whom there would be no suitable brace size in the Thuasne range.
* Patients participating in another clinical study or who have tested an experimental drug within 30 days prior to study entry. - Patients with another disease which, according to the investigator, may interfere with the results or the conduct of the trial and thus justify their non-inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01508728
Study Brief:
Protocol Section:
NCT01508728