Clinical trial NCT06507241: Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
Official title: Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meniscus Tear
Meniscus Lesion
Knee Injuries
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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 outcomes:
measure: RMN
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Weight-bearing ultrasound
timeFrame: 24 months after surgery
measure: Physical examination
timeFrame: 24 months after surgery
measure: International Knee Documentation Committee (IKDC)
timeFrame: 24 months after surgery
measure: Lysholm Knee Score
timeFrame: 24 months after surgery
measure: VAS (Visual Analog Scale)
timeFrame: 24 months after surgery
measure: Tegner Score
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: