Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 10 Years.

NCT ID: NCT06522152

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2030-07-31

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.

Conditions

Meniscus Disorder; Arthritis Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Zaffagnini

Role: CONTACT

stefano.zaffagnini@ior.it

0516366075

Facility Contacts

Stefano Zaffagnini

Role: primary

stefano.zaffagnini@ior.it

0516366075

Other Identifiers

MAT 10 Y

Identifier Type: -

Identifier Source: org_study_id