Status:
COMPLETED
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
Lead Sponsor:
Mastelli S.r.l
Conditions:
Meniscus Tear
Meniscus Lesion
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a non-randomized multicentre study for the evaluation of the clinical performance and safaty of the augmentation-to-surgery and conservative treatments for the degenerative meniscopathies, wit...
Detailed Description
Meniscal tear plays a significant role among the multitude of ethiologies of knee pain. In the setting of chronic meniscus degeneration, healing potential remains low due to a vascular penetration of ...
Eligibility Criteria
Inclusion
- Male or female subjects with age between 18 and 65 years
- Presence of symptomatic degenerative meniscus tear
- Presence of one of the following unilateral symptoms: pain, catching, or locking of the knee
- Non responsive to physical therapy for at least 3-4 weeks
- Be in neutral alignment +/- 5 degrees of the mechanical axis
- Subject must be physically and mentally willing and able to comply with the study follow-up schedule
- Subject must sign Ethic committe approved informed consent
- Subject is willing and able to comply with all study procedures, including visits and diagnostic procedures
Exclusion
- Radiographic osteoarthritis of the knee in any compartment greater than Kellgren-Lawrence (KL) grade 3.
- Presence of bone marrow edema (BME) at the index knee.
- Presence of knee instability.
- Have a varus or valgus knee deformity \> 5 degrees.
- Have meniscal roots tears.
- Have discoid meniscus.
- Have patella instability or non-anatomically positioned patella.
- Have a knee flexion contracture \> 10 degrees.
- Be unable to flex the knee to 90 degrees.
- Have a leg length discrepancy causing a noticeable limp.
- Have an active infection or tumor.
- Have any type of knee joint inflammatory disease including Sjogren's syndrome.
- Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric or cognitive conditions.
- Participation to another clinical trial or clinical investigation in the previous 3 months.
- BMI \> 35.
- Prior knee arthroscopy within 6 months of study enrolment.
- Unable to have an MRI scan.
- Known allergy, sensitivity or intolerance to any of the components of the investigational device or to products originating from fish.
- Positive history of human immunodeficiency virus antibodies, hepatitis B surface antigen or hepatitis C virus antibodies.
- Autoimmune diseases, rheumatoid disease eg. Lupus erythematosus.
- The subject is currently being treated with radiation and or chemotherapy.
- Previous or ongoing alcohol abuse or dependence, use of illicit drugs within 1 year prior to enrolment.
- Patients who are pregnant or planning to become pregnant during the planned period of participation in the study or who are breastfeeding. Women of child-bearing age must consent to use and actually make use of a highly effective contraceptive method, considered acceptable by the investigator, for the whole study duration.
- Does not agree to participate.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05322005
Start Date
October 26 2020
End Date
July 27 2024
Last Update
August 12 2025
Active Locations (2)
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1
Peter Verdonk
Deurne, Belgium, 2100
2
Elizaveta Kon
Milan, Milan, Italy, 20089