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.
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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Rizzoli Ortopedic Institute
Bologna, Bologna, 40136
stefano zaffagnini, 0516366075, stefano.zaffagnini@ior.it
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.
- Conditions
- Ligament Injury, Knee Injuries
- Medical subject headings
- Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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.
- First posted15 Sep 2025
- Study start10 Sep 2025
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07174219
- Acronym / sponsor ID
- STENER_MCL / STENER_MCL
- Conditions
- Ligament Injury, Knee Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lysholm Knee Score
Time frame: At least 24 months after surgery
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).
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.