Meniscus DisorderMAT 10 YNCT06522152
Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 10 Years.
An observational study of Meniscus Disorder and Arthritis Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus Disorder, Arthritis Knee
- How many people
- 397 participants
- Where
- 1 siteItaly
- Study dates
- 24 Oct 2024to Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 10 years
Secondary outcomes (3)
VAS
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.
Measured: 10 years
Tegner Score
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.
Measured: 10 years
KOOS score
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start24 Oct 2024
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus DisorderStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522152
- Sponsor's protocol ID
- MAT 10 Y
- Acronym
- MAT 10 Y
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 10 Years.
- ClinicalTrials.gov ID
- NCT06522152
- Acronym / sponsor ID
- MAT 10 Y / MAT 10 Y
- Conditions
- Meniscus Disorder, Arthritis Knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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).
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 scale.
3 secondary outcomes
VAS
Time frame: 10 years
Tegner Score
Time frame: 10 years
KOOS score
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Disorder and Arthritis Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Zaffagnini (0516366075, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.