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

NCT06507241 | Recruiting DMC

• 1 other identifier: ROOT-PCL
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meniscus Tear; Meniscus Lesion; Knee Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months after surgery

Secondary Outcomes (6)

• Weight-bearing ultrasound

  24 months after surgery

• Physical examination

  24 months after surgery

• International Knee Documentation Committee (IKDC)

  24 months after surgery

• Lysholm Knee Score

  24 months after surgery

• VAS (Visual Analog Scale)

  24 months after surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Stefano Zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 18, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

IT (1)