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Clinical Trials/NCT06507241
NCT06507241
Recruiting
Not Applicable

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

Istituto Ortopedico Rizzoli1 site in 1 country59 target enrollmentOctober 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Tear
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
59
Locations
1
Primary Endpoint
RMN
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2024
End Date
December 1, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • International Knee Documentation Committee (IKDC)(24 months after surgery)
  • Physical examination(24 months after surgery)
  • Tegner Score(24 months after surgery)
  • Weight-bearing ultrasound(24 months after surgery)
  • Lysholm Knee Score(24 months after surgery)
  • VAS (Visual Analog Scale)(24 months after surgery)

Study Sites (1)

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