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

NCT ID: NCT07174219

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2030-08-31

Brief 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.

Conditions

Ligament Injury; Knee Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefano Zaffagnini

OTHER

Sponsor Role: lead

Responsible Party

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Rizzoli Ortopedic Institute

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

stefano zaffagnini

Role: CONTACT

stefano.zaffagnini@ior.it

0516366075

Facility Contacts

stefano zaffagnini

Role: primary

stefano.zaffagnini@ior.it

0516366075

Other Identifiers

STENER_MCL

Identifier Type: -

Identifier Source: org_study_id