Meniscal DegenerationSUPER CMINCT06597357
Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds (CMI)
An observational study of Meniscal Degeneration and Osteoarthritis of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscal Degeneration, Osteoarthritis of Knee, Meniscus Injury
- What is being tested?
- Arthroscopy & saline irrigation alone
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 29 Nov 2020to 29 Nov 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients, upon signing the informed consent, will be clinically evaluated during the follow-up visit by specialized medical personnel. A clinical examination will be performed, including the administration of subjective assessment questionnaires, and weight-bearing radiographs of the lower limbs will be conducted.
Who may be able to join
- Patients aged between 18 and 65 years at the time of surgery
- Both male and female patients
- Patients who underwent meniscectomy and/or CMI implantation from January 1, 1998 to December 31, 2010 at the Rizzoli Orthopedic Institute.
Who cannot join
- Patients who are no longer reachable;
- Patients who do not consent to be included in the study;
- Presence of infection or hematological, rheumatic, or hemostatic disorders at the time of evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal sutures (where possible) to preserve as much meniscus as possible. Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis.
However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical option. Over time, months or years later, a subgroup of patients may develop symptoms such as pain, joint swelling, and mechanical overload of the compartment that underwent meniscectomy, a condition known as post-meniscectomy syndrome..A portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement.
In an attempt to treat this condition, scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery. The goal is to reduce the incidence of long-term osteoarthritis and, consequently, the need for more invasive procedures. To date, no study has definitively demonstrated the real efficacy of these scaffolds (CMI), particularly regarding chondroprotection and the long-term onset of osteoarthritis.
- Being tested
- Arthroscopy & saline irrigation alone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopy & saline irrigation aloneProcedure or surgery
the meniscus scaffold is aimed at replacing partial meniscus defect with a synthetic device.
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC):
The IKDC form is a subjective knee evaluation module that reflects the limitations on activities the individual can perform in daily life and sports, as well as the presence or absence of symptoms.
There are three main domains in the IKDC evaluation form: Symptoms, which include pain, stiffness, swelling, and a sensation of locking; Sports and daily activities; Current knee function and function prior to injury. The questionnaire consists of 10 questions: seven items investigate the patient\'s symptoms, one item is focused on sports participation, one item-composed of 9 points-addresses the difficulties the patient experiences in performing daily life activities, and the last item measures the current functionality of the knee.
The score ranges from 0 to 100, with 100 representing the absence of limitations and symptoms, indicating an excellent outcome; the further away from this score, the worse the result, which can be divided into four groups
Measured: 10 years after surgery
Secondary outcomes (5)
Lysholm Knee Score
It is a validated measurement scale that assesses knee functionality through 8 items, allowing the evaluation of the knee\'s condition in response to the functional demands of daily activities. This assessment form is used to evaluate surgical outcomes in patients who have undergone surgery for ligament or meniscal injuries of the knee. The final score is obtained by summing the various scores from 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 after surgery
VAS
It is a unidimensional, quantitative numeric pain rating scale with 10 points; 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 after surgery
SF-36 (Short Form-36 Health Survey)
It is the most well-known and widely used health-related quality of life measurement tool in international literature. It assesses different health concepts through 36 multiple-choice questions, with the data aggregated into 8 scales that evaluate: physical activity, role and physical health, physical pain, general health, vitality, social activities, role and emotional state, mental health. Additionally, there is one question regarding changes in health status over the past year.
Measured: 10 years after surgery
Tegner Score
It allows for estimating a person\'s level of physical activity with a score ranging from 0 to 10, where 0 represents \'inability\' and 10 represents \'participation in competitive sports, such as national or international level football.\' This score is the most commonly used to define the level of physical 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 after surgery
Radiographic evaluation
Clinical and imaging materials in the patient\'s possession will be collected to assess the potential development of osteoarthritis.
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Nov 2020
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal DegenerationStudies 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
- 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
- NCT06597357
- Sponsor's protocol ID
- SUPER CMI
- Acronym
- SUPER CMI
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds (CMI)
- ClinicalTrials.gov ID
- NCT06597357
- Acronym / sponsor ID
- SUPER CMI / SUPER CMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 19 Sep 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.
Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal sutures (where possible) to preserve as much meniscus as possible. Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis.
However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical option. Over time, months or years later, a subgroup of patients may develop symptoms such as pain, joint swelling, and mechanical overload of the compartment that underwent meniscectomy, a condition known as post-meniscectomy syndrome..A portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement.
In an attempt to treat this condition, scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery. The goal is to reduce the incidence of long-term osteoarthritis and, consequently, the need for more invasive procedures. To date, no study has definitively demonstrated the real efficacy of these scaffolds (CMI), particularly regarding chondroprotection and the long-term onset of osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- 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
- Patients, upon signing the informed consent, will be clinically evaluated during the follow-up visit by specialized medical personnel. A clinical examination will be performed, including the administration of subjective assessment questionnaires, and weight-bearing radiographs of the lower limbs will be conducted.
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years at the time of surgery
- Both male and female patients
- Patients who underwent meniscectomy and/or CMI implantation from January 1, 1998 to December 31, 2010 at the Rizzoli Orthopedic Institute.
Key exclusion criteria (3 listed)
- Patients who are no longer reachable;
- Patients who do not consent to be included in the study;
- Presence of infection or hematological, rheumatic, or hemostatic 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopy & saline irrigation alonethe meniscus scaffold is aimed at replacing partial meniscus defect with a synthetic device. | Procedure or surgery | – |
Primary outcome
International Knee Documentation Committee (IKDC):
Time frame: 10 years after surgery
The IKDC form is a subjective knee evaluation module that reflects the limitations on activities the individual can perform in daily life and sports, as well as the presence or absence of symptoms. There are three main domains in the IKDC evaluation form: Symptoms, which include pain, stiffness, swelling, and a sensation of locking; Sports and daily activities; Current knee function and function prior to injury. The questionnaire consists of 10 questions: seven items investigate the patient\'s symptoms, one item is focused on sports participation, one item-composed of 9 points-addresses the difficulties the patient experiences in performing daily life activities, and the last item measures the current functionality of the knee. The score ranges from 0 to 100, with 100 representing the absence of limitations and symptoms, indicating an excellent outcome; the further away from this score, the worse the result, which can be divided into four groups
5 secondary outcomes
Lysholm Knee Score
Time frame: 10 years after surgery
VAS
Time frame: 10 years after surgery
SF-36 (Short Form-36 Health Survey)
Time frame: 10 years after surgery
Tegner Score
Time frame: 10 years after surgery
Radiographic evaluation
Time frame: 10 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Meniscal Degeneration and Osteoarthritis of 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC): (time frame: 10 years after surgery). 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 19 Sep 2024.