Clinical trial NCT05322005: Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
Official title: A Non-randomized Multicentre Study for the Evaluation of the Clinical Performance and Safety of the Augmentation-to-surgery and Conservative Treatments for the Degenerative Meniscopathy, With Injection of Polynucleotide Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Tear
Meniscus Lesion
Lead sponsor: Mastelli S.r.l
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment A (augmentation-to-surgery): subjects surgically treated with partial meniscectomy combined with an intraarticular and intra-meniscal injection of polynucleotide gel.

Treatment B (conservative): subjects treated with three injections session of polynucleotide gel.
Primary purpose: TREATMENT

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, with injection of polynucleotide gel.

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 less than one-third of the adult meniscus. Currently, both conservative and surgical modalities can be utilized in the treatment of the painful degenerative menisci, and no gold standard treatment has been identified. Polynucleotide gel Condrotide® is a polynucleotide solution, used in case of degenerative painful join pathologies, favouring the physiological mechanism of joint repair because of the capacity to normalize the viscosity of synovial fluid and supposed to improve the joint trophism. The present study aims at evaluating the capacity of the polynucleotide gel injection to stimulate healing and slow down progression of meniscal degeneration, through augmentation-to-surgery and conservative treatments for the degenerative meniscopathies.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects with age between 18 and 65 years
2. Presence of symptomatic degenerative meniscus tear
3. Presence of one of the following unilateral symptoms: pain, catching, or locking of the knee
4. Non responsive to physical therapy for at least 3-4 weeks
5. Be in neutral alignment +/- 5 degrees of the mechanical axis
6. Subject must be physically and mentally willing and able to comply with the study follow-up schedule
7. Subject must sign Ethic committe approved informed consent
8. Subject is willing and able to comply with all study procedures, including visits and diagnostic procedures

Exclusion Criteria:

1. Radiographic osteoarthritis of the knee in any compartment greater than Kellgren-Lawrence (KL) grade 3.
2. Presence of bone marrow edema (BME) at the index knee.
3. Presence of knee instability.
4. Have a varus or valgus knee deformity \> 5 degrees.
5. Have meniscal roots tears.
6. Have discoid meniscus.
7. Have patella instability or non-anatomically positioned patella.
8. Have a knee flexion contracture \> 10 degrees.
9. Be unable to flex the knee to 90 degrees.
10. Have a leg length discrepancy causing a noticeable limp.
11. Have an active infection or tumor.
12. Have any type of knee joint inflammatory disease including Sjogren's syndrome.
13. Have neuropathic knee osteoarthropathy, also known as Charcot joint.
14. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric or cognitive conditions.
15. Participation to another clinical trial or clinical investigation in the previous 3 months.
16. BMI \> 35.
17. Prior knee arthroscopy within 6 months of study enrolment.
18. Unable to have an MRI scan.
19. Known allergy, sensitivity or intolerance to any of the components of the investigational device or to products originating from fish.
20. Positive history of human immunodeficiency virus antibodies, hepatitis B surface antigen or hepatitis C virus antibodies.
21. Autoimmune diseases, rheumatoid disease eg. Lupus erythematosus.
22. The subject is currently being treated with radiation and or chemotherapy.
23. Previous or ongoing alcohol abuse or dependence, use of illicit drugs within 1 year prior to enrolment.
24. 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.
25. Does not agree to participate.

Primary outcomes:
measure: Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured
timeFrame: 24 months (end of follow up)
Secondary outcomes:
measure: The change of the radiological assessment of the cartilage by a 5-points Likert scale
timeFrame: 24 months
measure: The change of the International Knee Documentation Committee (IKDC Questionnaire)
timeFrame: 24 months
measure: The change of the Tegner activity score from baseline (V1) to 3 (V5), 6 (V6), 12 (V7), 24 (V8) months after treatment completion (T0).
timeFrame: 24 months
measure: AE and device deficiencies Reporting
timeFrame: 24 months
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: Peter Verdonk
city: Milan
country: Italy
facility: Elizaveta Kon
Study officials:
affiliation: Plastic surgery IRCCS Humanitas
name: Elizaveta Kon, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Monica Ziekenhuizen Antwerpen en Deurne
name: Peter Verdonk, Prof.
role: PRINCIPAL_INVESTIGATOR
References: