NCT06522152 Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 10 Years.
| NCT ID | NCT06522152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Meniscus Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 397 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2030-07 |
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 397 participants in total. It began in 2024-10-24 with a primary completion date of 2030-07.
⚠ 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
Menisci are crescent-shaped cartilage structures that are fundamentally important for the biomechanics and physiology of the knee joint. They play a primary role in load transmission, assist the ligaments in ensuring knee stability, and thus protect against the onset of knee osteoarthritis. Meniscal injuries are the most frequently encountered joint pathology and can cause pain, mechanical blocks, and recurrent effusions. The treatment of these injuries has progressively evolved from meniscectomy (removal of damaged meniscal tissue) to the use of meniscal sutures (where possible) to allow the preservation of the greatest amount of meniscus: numerous studies have shown a correlation between the amount of meniscus removed and the future onset of osteoarthritis (Hutchinson AJSM 2014, Harston KSSTA 2012). However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical solution even today. Over time, months or years later, a subgroup of patients experiences symptoms such as pain, joint swelling, and mechanical overload of the compartment subjected to meniscectomy, a condition known as "post-meniscectomy syndrome." Some of these patients will subsequently develop knee osteoarthritis, requiring invasive interventions such as partial or total knee replacement. Meniscal allograft transplantation (MAT) represents a valid therapeutic option for post-meniscectomy syndrome. This procedure aims to restore joint functionality and stability through the transplantation of a meniscus from a cadaver donor. MAT has been widely adopted in clinical practice, showing success in reducing pain and improving joint functionality. Current studies suggest that meniscal transplantation can offer significant protection against osteoarthritis, but the duration of this preventive effect is not yet fully understood. Furthermore, there are no studies that can demonstrate the state of osteoarthritis with radiographic controls pre- and post-treatment at a follow-up of over 10 years.
Eligibility Criteria
Inclusion Criteria: * Patients aged between 18 and 65 at the time of surgery * Both male and female * Patients who underwent meniscal transplantation at the Rizzoli Orthopedic Institute at least 10 years ago Exclusion Criteria: * Patients who do not give consent to be included in the study * Patients who are no longer reachable * Presence of infection or hematologic, rheumatic, or coagulation disorders at the time of evaluation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06522152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Meniscus Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06522152 currently recruiting?
Yes, NCT06522152 is actively recruiting participants. Contact the research team at stefano.zaffagnini@ior.it for enrollment information.
Where is the NCT06522152 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06522152 clinical trial?
NCT06522152 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 397 participants.