Status:
ENROLLING_BY_INVITATION
Prevention of Post mEniscectomy Osteoarthritis: From New Animal Model to Patient pRofiLing
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Azienda Ospedaliero Universitaria di Sassari
Conditions:
Meniscopathy
Eligibility:
All Genders
19+ years
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 t...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06906094
Start Date
April 15 2024
End Date
April 15 2025
Last Update
April 9 2025
Active Locations (3)
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1
Galeazzi Orthopaedic Institute
Milan, Milano, Italy, 20157
2
Irccs Humanitas Research Hospital
Milan, Rozzano, Italy, 20089
3
UNISS Università Degli Studi Di Sassari
Sassari, Italy, 07100