Clinical trial NCT06522152: Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 15 Years.
Official title: Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 15 Years.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meniscus Disorder
Arthritis Knee
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 251 patients will be considered, recruited from all individuals who underwent meniscal transplantation at the Rizzoli Orthopedic Institute between June 2004 and October 2015, and who were previously recruited for the MAT study.

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.


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 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

Primary outcomes:
measure: Lysholm Knee Score
timeFrame: 15 years
measure: Kellgren-Lawrence scale
timeFrame: 15 years
Secondary outcomes:
measure: VAS
timeFrame: 15 years
measure: Tegner Score
timeFrame: 15 years
measure: KOOS score
timeFrame: 15 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: