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

NCT06906094 | Enrolling By Invitation DMC

• 1 other identifier: Protocol ID: 2801 Study N:3421
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

meniscectomy; surgery

Outcome Measures

Primary Outcomes (4)

• Primary objective

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

  6-12 months

• Primary objective

  Describing the clinical profile of patient

  6-12 months

• Primary objective

  Describing the morphological profile of patient

  6-12 months

• Primary objective

  Describing the miRNA profile of patient

  6-12 months

Secondary Outcomes (2)

• Secondary objectives

  12 months

• Secondary objectives

  12 months

Interventions

Selective meniscectomy PROCEDURE

involves the partial removal of the damaged meniscus.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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;

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator
• Azienda Ospedaliero Universitaria di Sassari: collaborator

Study Sites (3)

Galeazzi Orthopaedic Institute

Milan, Milano, 20157, Italy

Location

Irccs Humanitas Research Hospital

Milan, Rozzano, 20089, Italy

Location

UNISS Università Degli Studi Di Sassari

Sassari, 07100, Italy

Location

Related Publications (2)

• 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.

  PMID: 34534661 BACKGROUND

• 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.

  PMID: 21247936 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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 esclude 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.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 2, 2025
• Study Start: April 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: April 15, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

IT (3)