Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgical… (NCT07174219) | Clinical Trial Compass
RecruitingNot Applicable
Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures
Italy43 participantsStarted 2025-09-10
Plain-language summary
The knee is a complex joint stabilized by four main ligaments: the anterior and posterior cruciate ligaments and the medial and lateral collateral ligaments. Multiligamentous knee injuries involve at least two ligaments and usually result from high-energy trauma, causing significant functional limitations.
One specific injury is the "Stener-like" lesion of the medial collateral ligament (MCL), characterized by an avulsion at its distal tibial insertion with interposition of tendons from the pes anserinus, which prevents natural healing. This lesion often occurs with other ligament or bone injuries and requires surgical treatment.
Diagnosis is clinical, supported by MRI to confirm the distal lesion and tendon interposition. Despite its importance, literature on this injury is scarce, with only a few studies and case reports, often limited by small sample sizes and lack of standardized follow-up assessments.
Due to the rarity and complexity of these injuries, there is a need for a comprehensive clinical study with standardized evaluations to improve understanding and develop standardized surgical treatments for isolated and associated Stener-like MCL lesions.
Who can participate
Age range
12 Years – 65 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:
* Patients of both male and female sex.
* Patients who underwent surgical re-insertion of the distal insertion of the medial collateral ligament starting from 01/01/2020 and all patients scheduled for this type of surgical intervention until 12/31/2027;
* Patients aged between 12 and 65 years at the time of surgery;
* Patients who underwent isolated distal medial collateral ligament re-insertion surgery, as well as those who underwent the same procedure combined with other interventions on the same knee (e.g., multiligament injuries, reduction and osteosynthesis of bone fractures);
* Patients who have given consent to participate in the study;
* Patients who have undergone preoperative radiological investigations of the affected knee confirming the diagnosis of distal medial collateral ligament injury (MRI in the case of ligament injuries; X-ray and/or CT scan in the case of articular fractures).
Exclusion Criteria:
* Previous fractures of the same limb treated surgically.
* Patient age under 12 years at the time of surgery or patients over 65 years of age.
* Patients who have not provided informed consent.
* Patients who are no longer contactable.
* Patients who have not engaged in sports activity in the 2 years prior to the surgical intervention.
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.