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

NCT06522152 | Recruiting DMC

• 1 other identifier: MAT 10 Y
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Lysholm Knee Score

  It is a validated measurement scale that assesses knee functionality through 8 items, which allow for determining the condition of the knee in response to the functional demands of daily life activities. This evaluation form is used to assess the outcomes of surgery on patients operated on for ligamentous or meniscal knee injuries. The final score is obtained by summing the various scores obtained in the different items, ranging from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).

  10 years

• Kellgren-Lawrence scale

  Clinical and imaging material in the patient's possession will be collected to evaluate the potential development of osteoarthritis. If the patient does not have radiological documentation performed according to the study protocol within the last 12 months, a weight-bearing knee X-ray in two projections will be performed to assess the degree of osteoarthritis according to the Kellgren-Lawrence scale.

  10 years

Secondary Outcomes (3)

• VAS

  10 years

• Tegner Score

  10 years

• KOOS score

  10 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 397 patients will be considered, recruited from all individuals who underwent meniscal transplantation at the Rizzoli Orthopedic Institute between June 2004 and October 2020, and who were previously recruited for the MAT study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Central Study Contacts

Stefano Zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IT (1)