NCT06522152: MAT 10 Y

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

Recruiting now Last updated 1 August 2025

What this trial tests

trial in Meniscus Disorder in 397 participants. Currently enrolling.

Timeline

24 October 2024

Primary endpoint
1 July 2030

1 July 2030

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	397
Start date	24 October 2024
Primary completion	1 July 2030
Estimated completion	1 July 2030
Sites	1 location across Italy

Conditions studied

• Meniscus Disorder — all drugs for Meniscus Disorder →
• Arthritis Knee — all drugs for Arthritis Knee →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 65, any sex, with Meniscus Disorder or Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Lysholm Knee Score
  Time frame: 10 years
  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
• Kellgren-Lawrence scale
  Time frame: 10 years
  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 sca

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.