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Recruiting NCT07174219

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

Observational Ligament Injury Knee Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ligament Injury, Knee Injuries. Basic parameters: 12 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Lysholm Knee Score [Time frame: At least 24 months after surgery]
Secondary outcome measures (9)
  • KT-1000 Arthrometer [Time frame: At least 24 months after surgery]
  • KIRA Accelerometer [Time frame: At least 24 months after surgery]
  • Anterior drawer test [Time frame: At least 24 months after surgery]
  • Return to sports [Time frame: At least 24 months after surgery]
  • VAS (Visual Analog Scale) [Time frame: At least 24 months after surgery]
  • Tegner Score [Time frame: At least 24 months after surgery]
  • International Knee Documentation Committee (IKDC) [Time frame: At least 24 months after surgery]
  • Complications or Subsequent Interventions [Time frame: At least 24 months after surgery]
  • Radiographic Evaluation [Time frame: At least 24 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Rizzoli Ortopedic Institute — Bologna

Identifiers

NCT: NCT07174219 · STENER_MCL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗