AzTrials
AzTrials

Ligament InjurySTENER_MCLNCT07174219

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

An observational study of Ligament Injury and Knee Injuries, run by Stefano Zaffagnini at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Ligament Injury, Knee Injuries
How many people
43 participants
Where
1 siteItaly
Study dates
10 Sep 2025to Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

stefano zaffagnini contact

0516366075

stefano.zaffagnini@ior.it

Italy1 site, 1 recruiting
  • IRCCS Rizzoli Ortopedic Institute

    Bologna, Bologna, 40136

    stefano zaffagnini, 0516366075, stefano.zaffagnini@ior.it

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Medical subject headings
Knee Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At least 24 months after surgery

Secondary outcomes (9)
  1. 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.

    Measured: At least 24 months after surgery

  2. 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).

    Measured: At least 24 months after surgery

  3. 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.

    Measured: At least 24 months after surgery

  4. 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.

    Measured: At least 24 months after surgery

  5. VAS (Visual Analog Scale)

    The VAS is a unidimensional 10-point numeric scale used to quantify pain, represented by a 10 cm horizontal line without visible numbers, with endpoints marked as "no pain" (0) and "worst possible pain" (10). The patient marks a point on the line representing their current pain intensity, and the clinician measures the distance from zero to quantify the pain. This scale will be used to assess pain before and after surgery in the lateral compartment of the knee. Pain at the site of metal plate placement for lateral tenodesis fixation scoring above 2 on the VAS will be considered significant lateral compartment pain; scores of 2 or less will be considered as absence of pain in this area.

    Measured: At least 24 months after surgery

  6. Tegner Score

    The Tegner Score estimates a person's level of physical activity on a scale from 0 to 10, where 0 represents 'disability' and 10 represents 'participation in competitive sports,' such as national or international level soccer. This score is the most commonly used to define the activity level of patients with knee disorders. In the study, the Tegner Score will be completed by the investigator through an interview with the patient.

    Measured: At least 24 months after surgery

  7. International Knee Documentation Committee (IKDC)

    The IKDC questionnaire is a subjective knee evaluation tool that assesses limitations in daily and sports activities, as well as the presence or absence of symptoms. It focuses on three main domains: symptoms (pain, stiffness, swelling, locking), sports and daily activities, and current versus pre-injury knee function. The questionnaire includes 10 questions: seven about symptoms, one about sports participation, one about difficulties in daily activities, and one about current knee function. Scores range from 0 to 100, where 100 indicates no symptoms or limitations (excellent result). Scores are classified as excellent (80-100), good (60-80), fair (30-60), and poor (0-30).

    Measured: At least 24 months after surgery

  8. Complications or Subsequent Interventions

    Any complications and subsequent interventions will be documented and recorded in the Case Report Form (CRF). The staff responsible for distributing and collecting the questionnaires will place an identification code on the front page of each questionnaire to ensure the privacy of the study participants.

    Measured: At least 24 months after surgery

  9. Radiographic Evaluation

    Clinical and imaging materials available from the patient will be collected. Additionally, as part of standard clinical practice, anteroposterior (AP) radiographs of the lower limb will be performed, along with a second AP radiograph under valgus stress to assess the degree of medial compartment opening when the knee is stressed in valgus. This approach avoids the usual lateral radiograph typically performed during a standard two-view knee X-ray.

    Measured: At least 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start10 Sep 2025
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174219
Sponsor's protocol ID
STENER_MCL
Acronym
STENER_MCL
Status last verified
Sep 2026
First submitted
8 Sep 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ligament Injury and Knee Injuries, run by Stefano Zaffagnini at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact stefano zaffagnini (0516366075, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lysholm Knee Score (time frame: At least 24 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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