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

NCT06906094 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-04-09

No results posted yet for this study

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 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.

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.

Conditions

  • Meniscopathy

Interventions

PROCEDURE

Selective meniscectomy

involves the partial removal of the damaged meniscus.

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    collaborator OTHER

  • Azienda Ospedaliero Universitaria di Sassari

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-10-15
Completion
2025-04-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906094 on ClinicalTrials.gov