About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
KT-1000 Arthrometer
The KT-1000 is an objective evaluation tool that measures anterior tibial translation relative to the position of the femur by applying a predefined force pushing the tibia forward. It is commonly used in research to quantitatively assess static knee laxity in the anteroposterior direction following anterior cruciate ligament reconstruction surgery.
KIRA Accelerometer
KIRA is a non-invasive outpatient device that allows the assessment of dynamic laxity during the pivot shift phenomenon. The device enables precise quantification of the extent of laxity. The unit of measurement is millimeters per second squared (mm/s²).
Anterior drawer test
This test allows evaluation of the anterior translation of the tibia relative to the femur with the knee flexed at 90 degrees. An increased translation suggests an anterior cruciate ligament (ACL) injury. It is graded on a scale from 0 to 3.
Return to sports
Using targeted questionnaires previously applied in the same clinical unit, the type, level, and frequency of sports activity before injury and at follow-up will be investigated. Validated scores such as the Sports Score and IMPACT activity level score will be used. The SPORTS (Subjective Patient Outcome for Return To Sports) Score is a subjective questionnaire that assesses the level of return to sports compared to pre-injury condition on a numeric scale (0, 3, 6, 9, 10) alongside a verbal rating from "disabled" (0) to "good" (10). The IMPACT activity level score objectively evaluates knee impact based on the type of sport, classifying activities into "Low," "Intermediate," and "High" impact. This allows comparison of the sport impact level before and after surgery.
Sponsors and contacts
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Stefano Zaffagnini
Lead sponsor
Istituto Ortopedico Rizzoli
Sponsor institution