Meniscus TearROOT-PCLNCT06507241
Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
An observational study of Meniscus Tear and Meniscus Lesion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The menisci are crucial for knee stability and functionality. Composed of fibrocartilaginous structure, they have an anatomical and biomechanical arrangement that makes them essential for load transmission and the prevention of osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Tear, Meniscus Lesion, Knee Injuries
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2024to Dec 2027
- How long will I take part?
- 2 Years
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited among all subjects with "ROOT" type meniscal lesions treated surgically with arthroscopic suturing to the posterior cruciate ligament (ROOT-PCL) from 1/1/2021 to 31/12/2025 at the Rizzoli Orthopedic Institute.
Who may be able to join
- Age between 18 and 50 years at the time of surgery;
- Male and female gender;
- Patients undergoing surgical treatment for at least one year for "ROOT" type meniscal lesions using arthroscopic suturing to the posterior cruciate ligament;
- Pre-operative MRI performed.
Who cannot join
- Patients no longer reachable;
- Patients who refuse consent to the study;
- Previous meniscectomy before surgery;
- Previous ligament injuries before surgery;
- New traumatic injuries after surgery;
- Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery;
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- Severe knee malalignment (> 5°) at the time of surgery;
- Severe obesity (BMI > 35);
- Lower limb conditions preventing full weight-bearing during evaluation;
- Infection or hematological/rheumatic conditions at the time of evaluation.
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 Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
The menisci are crucial for knee stability and functionality. Composed of fibrocartilaginous structure, they have an anatomical and biomechanical arrangement that makes them essential for load transmission and the prevention of osteoarthritis. Meniscal root lesions, known as "ROOT tears," compromise their protective function on the cartilage, leading to increased contact pressures between the tibia and femur and, over time, the development of osteoarthritis. Early diagnosis of these lesions is difficult and often the first detection is incidental. The subsequent challenges are significant due to a lack of pre-operative planning. A possible solution is a surgical technique involving arthroscopic suture of the posterior meniscal root along with the posterior cruciate ligament. This procedure does not require pre-operative planning and is applicable even in cases of incidental diagnosis.
- Conditions
- Meniscus Tear, Meniscus Lesion, Knee Injuries
- Medical subject headings
- Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
RMN
The 3 Tesla MRI is the diagnostic test of choice used in common clinical practice to evaluate the healing of these lesions at 1 and 2 years of follow-up. The measured parameter is meniscal extrusion. The measurement is taken in millimeters at the coronal sections visualizing the medial collateral ligament, from the capsular margin of the body to the outer profile of the tibial plateau. The "ghost sign" and tibial plateau edema will also be looked for. The main limitation of MRI is related to the fact that it is performed non-weight-bearing, with the patient in a supine position.
Measured: 24 months after surgery
Secondary outcomes (6)
Weight-bearing ultrasound
Weight-bearing ultrasound is a method not commonly used in clinical practice but extremely useful in evaluating meniscal extrusion under conditions close to physiology. The measurement is performed in a static position with the patient standing upright with full weight-bearing. Once again, meniscal extrusion is measured in millimeters in the coronal sections visualizing the medial collateral ligament, from the capsular margin of the body to the outer profile of the tibial plateau. The strength of this method lies in its ability to replicate the biomechanical stress phenomena affecting the menisci during common daily activities, with the potential to detect lesions that would otherwise remain silent in a non-weight-bearing MRI.
Measured: 24 months after surgery
Physical examination
A comprehensive assessment will include palpation to identify classic tender points related to meniscal pathology at the anterior, middle, and posterior joint lines. The presence of pain and the patient's overall health status will then be noted.
Measured: 24 months after surgery
International Knee Documentation Committee (IKDC)
The IKDC form evaluates knee function subjectively across three domains: Symptoms (including pain, stiffness, swelling, and locking), Sports and daily activities, and Current knee function compared to before injury. It consists of 10 questions focusing on symptoms, sports participation, daily activity difficulties, and current knee function. Scores range from 0 to 100, with higher scores indicating better knee health: excellent (80-100), good (60-80), fair (30-60), and poor (0-30).
Measured: 24 months after surgery
Lysholm Knee Score
It's a validated measurement scale that assesses knee functionality through 8 items, allowing to establish the knee's condition in relation to the functional demands of daily life activities. This assessment tool is used to evaluate surgical outcomes in patients who have undergone knee ligamentous or meniscal injuries. The final score is derived from the sum of various scores obtained across different items, ranging from 0 to 100. Scores are categorized into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (<64).
Measured: 24 months after surgery
VAS (Visual Analog Scale)
It is a quantitative one-dimensional numerical scale for pain assessment with 10 points; the scale requires the patient to select the number that best describes the intensity of their pain from 0 to 10 at that specific moment. 0 indicates no pain, while 10 indicates the worst possible pain.
Measured: 24 months after surgery
Tegner Score
It allows estimation of the level of motor activity of a subject with a score ranging 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 widely used to define the level of motor activity in patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview with the patient.
Measured: 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 posted18 Jul 2024
- Study start18 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 59 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507241
- Sponsor's protocol ID
- ROOT-PCL
- Acronym
- ROOT-PCL
- Status last verified
- Nov 2025
- First submitted
- 4 Jul 2024
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT06507241
- Acronym / sponsor ID
- ROOT-PCL / ROOT-PCL
- Conditions
- Meniscus Tear, Meniscus Lesion, Knee Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2024 (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 menisci are crucial for knee stability and functionality. Composed of fibrocartilaginous structure, they have an anatomical and biomechanical arrangement that makes them essential for load transmission and the prevention of osteoarthritis. Meniscal root lesions, known as "ROOT tears," compromise their protective function on the cartilage, leading to increased contact pressures between the tibia and femur and, over time, the development of osteoarthritis. Early diagnosis of these lesions is difficult and often the first detection is incidental. The subsequent challenges are significant due to a lack of pre-operative planning. A possible solution is a surgical technique involving arthroscopic suture of the posterior meniscal root along with the posterior cruciate ligament. This procedure does not require pre-operative planning and is applicable even in cases of incidental diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited among all subjects with "ROOT" type meniscal lesions treated surgically with arthroscopic suturing to the posterior cruciate ligament (ROOT-PCL) from 1/1/2021 to 31/12/2025 at the Rizzoli Orthopedic Institute.
Key inclusion criteria (4 listed)
- Age between 18 and 50 years at the time of surgery;
- Male and female gender;
- Patients undergoing surgical treatment for at least one year for "ROOT" type meniscal lesions using arthroscopic suturing to the posterior cruciate ligament;
- Pre-operative MRI performed.
Key exclusion criteria (10 listed)
- Patients no longer reachable;
- Patients who refuse consent to the study;
- Previous meniscectomy before surgery;
- Previous ligament injuries before surgery;
- New traumatic injuries after surgery;
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
RMN
Time frame: 24 months after surgery
The 3 Tesla MRI is the diagnostic test of choice used in common clinical practice to evaluate the healing of these lesions at 1 and 2 years of follow-up. The measured parameter is meniscal extrusion. The measurement is taken in millimeters at the coronal sections visualizing the medial collateral ligament, from the capsular margin of the body to the outer profile of the tibial plateau. The "ghost sign" and tibial plateau edema will also be looked for. The main limitation of MRI is related to the fact that it is performed non-weight-bearing, with the patient in a supine position.
6 secondary outcomes
Weight-bearing ultrasound
Time frame: 24 months after surgery
Physical examination
Time frame: 24 months after surgery
International Knee Documentation Committee (IKDC)
Time frame: 24 months after surgery
Lysholm Knee Score
Time frame: 24 months after surgery
VAS (Visual Analog Scale)
Time frame: 24 months after surgery
Tegner Score
Time frame: 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 19 Nov 2025.
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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 Meniscus Tear and Meniscus Lesion, run by Istituto Ortopedico Rizzoli 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 4 inclusion and 10 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 19 Nov 2025. 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?
RMN (time frame: 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 19 Nov 2025.