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MeniscopathyPEARLNCT06906094

Prevention of Post mEniscectomy Osteoarthritis: From New Animal Model to Patient pRofiLing

An observational study of Meniscopathy, run by Istituto Clinico Humanitas at 3 sites in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Data collection from patients included in the observational clinical study will be achieved by the following activities: A total of 100 patients with degenerative meniscal tears will be enrolled in the observational study and treated according to the current standard of care which consists in an arthroscopic partial… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Meniscopathy
What is being tested?
Selective meniscectomy
Type of treatment
Surgery or procedure
How many people
100 participants
Where
3 sitesItaly
Study dates
15 Apr 2024to 15 Apr 2025
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A total of 100 patients with degenerative meniscal tears will be enrolled in the observational study and treated according to the current standard of care which consists in an arthroscopic partial meniscectomy in all the three clinical operative Unit involved in the project.Demographic, anamnestic and clinical data (age, gender, BMI, habits, co-morbidities, pharmacological treatments) of the patients included in the observational clinical study will be collected. Clinical routine assessments will be performed before surgery to assess the overall condition of the joint. A morphological profiling based on the MRI will be performed on patients prior or after the surgery since no change in knee morphology is expected to occur. Clinical routine assessments will be performed also after treatment to check for possible joint changes after the surgery.

Who may be able to join

  • Signed Informed Consent Form;
  • Male or female patients ≥18 years of age at time of screening;
  • Patients physically and mentally able to comply with all aspects of the study, including the requirements for follow-up visits;
  • Patients suffering from symptomatic medial and/or lateral degenerative meniscal lesion identified at MRI with a surgical indication of arthroscopic partial meniscectomy;
  • In case of bilateral degenerative meniscus, patients with no or mild pain in the contralateral knee, defined as a score < 2 on a 0-10 numerical rating scale (NRS);
  • Patients who, before the last 3 months, have undergone and failed at least one prior conservative OA treatment (NSAIDs, physiotherapy, hydrokinesitherapy);
  • Body mass index (BMI) ≤ 40 kg/m2

Who cannot join

  • Presence of clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee
  • Patients who experienced traumatic injury at the index knee within 6 months prior to the procedure;
  • Patients with a history of invasive malignancies (except non- melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years;
  • Patients with known systemic disorders or any systemic inflammatory condition such as rheumatoid arthritis;
  • Patients with known metabolic bone diseases such as those affecting calcium metabolism;
  • Patients with a BMI greater than 40 kg/m2,
Show all 11Show fewer
  • Patients who abuse of the following substances: alcohol, recreational drugs;
  • Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
  • Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
  • Use of systemic immunosuppressants within 6 weeks prior to screening;
  • Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection;

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy3 sites
  • Galeazzi Orthopaedic Institute

    Milan, Milano, 20157

  • Irccs Humanitas Research Hospital

    Milan, Rozzano, 20089

  • UNISS Università Degli Studi Di Sassari

    Sassari, 07100

Other trials in Italy

About this study

Official title: Prevention of Post mEniscectomy Osteoarthritis: From New Animal Model to Patient pRofiLing (PEARL)

Data collection from patients included in the observational clinical study will be achieved by the following activities:

A total of 100 patients with degenerative meniscal tears will be enrolled in the observational study and treated according to the current standard of care which consists in an arthroscopic partial meniscectomy in all the three clinical operative Unit involved in the project.

Read more

Demographic, anamnestic and clinical data (age, gender, BMI, habits, co-morbidities, pharmacological treatments) of the patients included in the observational clinical study will be collected.

Clinical routine assessments will be performed before surgery to assess the overall condition of the joint. A morphological profiling based on the MRI will be performed on patients prior or after the surgery since no change in knee morphology is expected to occur. Clinical routine assessments will be performed also after treatment to check for possible joint changes after the surgery.

Before surgery, peripheral blood samples from each patient enrolled in the observational study will be collected. Total blood count will be registered and included in the set of the patients' data. Total RNA will be purified from the blood samples and integrity of each RNA sample will be evaluated to exclude possible degradation during the procedure.Total RNA will be preamplified to perform the qRT-PCR-based analysis sifting a well-described set of 754 miRNAs panel known for their involvement in several joint and blood cell types' homeostasis and activation. The most abundantly expressed and relevant miRNAs will be identified in the whole set of samples and included in the set of the patients' data. Combination and interpretation of the clinical, morphological, imaging and biomarker -omics data will follow in order to identify the patient characteristics that are more associated to the development of post-meniscectomy OA, following these steps: A patient registry (PEARL registry) containing all the anamnestic, clinical, radiological and morphological data, as well as the blood count and the most relevant and abundant miRNAs obtained through the transcriptomic analyses carried out during the study, will be generated.

Patients will be clinically and radiologically monitored at short- and long-term to evaluate the possible onset of OA post-meniscectomy. Any possible relevant clinical data and adverse events encountered during the patient's clinical path will be tracked.

Patients will be assigned to categories based on the PEARL registry data and their clinical outcome post- meniscectomy. This will help identifying possible risk factors and pre-treatment markers associated to the susceptibility of patients to develop post-meniscectomy OA.

An algorithm that will use the information gathered in the previous steps will be developed. This tool will allow to identify patients more likely to suffer from post-meniscectomy OA and therefore to help in the therapeutic choice. The constant updating of the register over time beyond the project duration will allow to obtain increasingly reliable and consolidated information to further strength the predictivity of the algorithm for choosing the best treatment based on the patients' characteristics.

Read the detailed description

Patient demographic, anamnestic, clinical, radiological and morphological data will be collected and reported in the database PEARL, assigning an individual ID to each patient. The most relevant and abundant miRNAs obtained through the transcriptomic analyses will be included too. Information about age, gender, body mass index, type of meniscal lesion, type of injury (if any), time of symptoms onset, general knee condition, previous surgical and/or pharmacological treatments, co-morbidities will be included too. Subjective knee evaluations of patients will be collected by using internationally accepted PROMs (Patient Reported Outcome Measures) among which IKDC (International Knee Documentation Committee) Objective Score, KOOS (Knee Injury and Osteoarthritis Outcome Score), VAS (Visual Analogue Score) Pain and EQ-5D-5L. All these data will be collected during the pre-surgical visit and on follow up. Two MRIs are planned for the study, during screening visit and at 6 months follow-up visit; at least one of the two MRIs will be performed with a 3D protocol to assess the bone component. Therefore,radiological and morphological data will include standard x-ray and MRI protocol implemented by metadata of 3D MRI protocol (near-isotropic 0.83mm T2 SPACE and near-isotropic 0.63mm proton density SPACE) when needed. Accurate 3D models of femur bone and cartilage, tibia bone and cartilage and menisci will be reconstructed from (near-)isotropic high-resolution 3D MRI scans. For morphology analysis, a 3D DESS MRI sequence will be complemented with modern clinical sequences for diagnostic purposes. Using the reconstructed 3D models, advanced landmark-based and statistical shape analyses will be performed. The extracted shape features from these analyses will then serve as input for conventional statistical algorithms or state-of-the-art machine learning techniques. Finally, the addition of standing full-leg radiographs gives more insights in the biomechanics of the complete lower-limb from hip to toe. Alignment of the femur with respect to the tibia will be evaluated in both coronal and sagittal plane. These alignment variables will then be used as input for conventional statistics and machine learning algorithms both separately and combined with the knee-specific shape features (cf. previous paragraph).

Data related to the high-throughput transcriptomic analyses will include the most expressed blood miRNAs for each patients. Data will be generated on the Applied Biosystems' QuantStudio' 12K Flex RealTime PCR System using Expression Suite Software. Quantitation will be assessed by the 'relative threshold' method (Crt method) that sets a threshold for each amplification individually that is based on the shape of the amplification curve. Data normalization will be performed with RefFinder tool that evaluates and screens stable candidates from extensive experimental datasets.

After publication, the raw data related to in vitro analyses as well as pre-clinical and clinical anonimazed data will be made available through an open access database.

The timing of analysis data of the study will be as follows:

  1. Enrollment and treatment of 100 patients with symptomatic degenerative meniscal lesions undergoing partial arthroscopic meniscectomy: 0-12 months.
  2. Transcriptomic analysis will be conducted on blood samples collected at the time of surgery from the patients enrolled in the observational clinical study. The final data will be available within six months after the last enrollment.
  3. Follow up evaluation: all the patients will be evaluated at 6 and 12 months. The PEARL registry will permit to eventually clinically and radiologically evaluate the patients also beyond the project duration to monitor the possible onset of post-meniscectomy OA also beyond the one year time limit. Their evaluation after the end of the project will strengthen the findings of the study with longer-term evaluation
Conditions
Meniscopathy
Being tested
Selective meniscectomy
Keywords
meniscectomy, surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective meniscectomyProcedure or surgery

    involves the partial removal of the damaged meniscus.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary objective

    To monitor the possible progression of post-meniscectomy OA one year after the treatment

    Measured: 6-12 months

  2. Primary objective

    Describing the clinical profile of patient

    Measured: 6-12 months

  3. Primary objective

    Describing the morphological profile of patient

    Measured: 6-12 months

  4. Primary objective

    Describing the miRNA profile of patient

    Measured: 6-12 months

Secondary outcomes (2)
  1. Secondary objectives

    1. To develop the PEARL Patient registry

    Measured: 12 months

  2. Secondary objectives

    To define specific pre-treatment markers and risk factors related to negative outcome in the long term

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start15 Apr 2024
  3. Primary completion15 Oct 2024
  4. Study completion15 Apr 2025 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906094
Sponsor's protocol ID
Protocol ID: 2801 Study N:3421
Acronym
PEARL
Status last verified
Apr 2025
First submitted
18 Mar 2025
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We are careful not to share patient data from our study and it is necessary that the other centres also agree on approval despite the fact that the Humanitas Research Hospital is the sponsor of the project.

Publications

  • Allen KD, Thoma LM, Golightly YM. Epidemiology of osteoarthritis. Osteoarthritis Cartilage. 2022 Feb;30(2):184-195. doi: 10.1016/j.joca.2021.04.020. Epub 2021 Sep 14.

    PubMed 34534661
  • Papalia R, Del Buono A, Osti L, Denaro V, Maffulli N. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. Br Med Bull. 2011;99:89-106. doi: 10.1093/bmb/ldq043. Epub 2011 Jan 19.

    PubMed 21247936

Questions about this trial

What is this clinical trial studying?

An observational study of Meniscopathy, run by Istituto Clinico Humanitas at 3 sites 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 7 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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?

Primary objective (time frame: 6-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906094, which also lists 2 linked publications.

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 9 Apr 2025.

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