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

NCT07174219 · tracked via the Priya Life Science Italy tracker

Sponsor

Stefano Zaffagnini

Phase

Observational

Started

2025-09-10

Last updated

2026-10-02

Condition(s) studied

Ligament InjuryKnee Injuries

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

Lysholm Knee Score — At least 24 months after surgery
It is a validated measurement scale that assesses knee function through 8 items, which help determine the condition of the knee in relation to the functional demands of daily activities. This assessment tool is used to evaluate the outcomes of surgery in patients operated on for ligament or meniscal injuries of the knee. The final score is obtained by summing the scores from the different items and ranges from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).

Trial sites (1)

Facility	City	Region	Status
IRCCS Rizzoli Ortopedic Institute	Bologna	Bologna	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07174219 on ClinicalTrials.gov ↗ ← All trials in Italy