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 | Recruiting DMC

• 1 other identifier: STENER_MCL
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Lysholm Knee Score

  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).

  At least 24 months after surgery

Secondary Outcomes (9)

• KT-1000 Arthrometer

  At least 24 months after surgery

• KIRA Accelerometer

  At least 24 months after surgery

• Anterior drawer test

  At least 24 months after surgery

• Return to sports

  At least 24 months after surgery

• VAS (Visual Analog Scale)

  At least 24 months after surgery

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited among both male and female subjects, aged 12 years or older and under 65 years at the time of surgery, who were surgically treated at the II Clinic of the Rizzoli Orthopedic Institute with distal medial collateral ligament reinsertion starting from 2020, as well as all patients scheduled for this type of surgical procedure up to 2027. Only patients with a minimum follow-up of 2 years from the date of surgery will be enrolled.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Rizzoli Ortopedic Institute

Bologna, Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

stefano zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

IT (1)