NCT06507241 Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
| NCT ID | NCT06507241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Meniscus Tear |
| Study Type | OBSERVATIONAL |
| Enrollment | 59 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 59 participants in total. It began in 2024-10-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06507241 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Meniscus Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06507241 currently recruiting?
Yes, NCT06507241 is actively recruiting participants. Contact the research team at stefano.zaffagnini@ior.it for enrollment information.
Where is the NCT06507241 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06507241 clinical trial?
NCT06507241 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 59 participants.