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Recruiting Observational

Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament

NCT06507241 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-18
Last updated
2025-11-19

Condition(s) studied

Meniscus TearMeniscus LesionKnee Injuries

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 and 50 years at the time of surgery; 2. Male and female gender; 3. Patients undergoing surgical treatment for at least one year for "ROOT" type meniscal lesions using arthroscopic suturing to the posterior cruciate ligament; 4. Pre-operative MRI performed. Exclusion Criteria: 1. Patients no longer reachable; 2. Patients who refuse consent to the study; 3. Previous meniscectomy before surgery; 4. Previous ligament injuries before surgery; 5. New traumatic injuries after surgery; 6. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery; 7. Severe knee malalignment (\> 5°) at the time of surgery; 8. Severe obesity (BMI \> 35); 9. Lower limb conditions preventing full weight-bearing during evaluation; 10. Infection or hematological/rheumatic conditions at the time of evaluation.

Primary outcome measure(s)

  • RMN — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06507241 on ClinicalTrials.gov ↗ ← All trials in Italy