Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 15 Years.

Recruiting

• Conditions: Arthritis Knee; Meniscus Disorder

• Registration Number: NCT06522152
• Lead Sponsor: Istituto Ortopedico Rizzoli

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 15 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-10-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 251

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 15 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kellgren-Lawrence scale	15 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 scale.
Lysholm Knee Score	15 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 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).

Secondary Outcome Measures

Name	Time	Method
VAS	15 years	It is a 10-point quantitative unidimensional numerical scale for pain assessment. The scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that precise moment. 0 means no pain, and 10 indicates the worst possible pain.
Tegner Score	15 years	It allows estimating the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as national or international level soccer.' This score is the most commonly used to define the level of motor activity in patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview with the patient.
KOOS score	15 years	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire aimed at assessing symptoms related to the knee joint in individuals with joint injuries or primary osteoarthritis. It evaluates knee functionality across 5 aspects: symptoms, pain, Activities of Daily Living (ADL), sports, and Quality of Life (QOL). The final score is obtained by summing the various scores from the different items and ranges from 0 to 100.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy