Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides

Last updated: April 7, 2025
Sponsor: Mastelli S.r.l
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

partial meniscectomy

Condrotide® (polynucleotides gel: class III medical device)

Clinical Study ID

NCT05322005
DDM22M
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe 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 studyfollow-up schedule

  7. Subject must sign Ethic committe approved informed consent

  8. Subject is willing and able to comply with all study procedures, including visitsand diagnostic procedures

Exclusion

Exclusion Criteria:

  1. Radiographic osteoarthritis of the knee in any compartment greater thanKellgren-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 outcomesmeasures, such as neurological, degenerative muscular, psychiatric or cognitiveconditions.

  15. Participation to another clinical trial or clinical investigation in the previous 3months.

  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 theinvestigational device or to products originating from fish.

  20. Positive history of human immunodeficiency virus antibodies, hepatitis B surfaceantigen 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 yearprior to enrolment.

  24. Patients who are pregnant or planning to become pregnant during the planned periodof participation in the study or who are breastfeeding. Women of child-bearing agemust consent to use and actually make use of a highly effective contraceptivemethod, considered acceptable by the investigator, for the whole study duration.

  25. Does not agree to participate.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: partial meniscectomy
Phase:
Study Start date:
October 26, 2020
Estimated Completion Date:
March 30, 2025

Study 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.

Connect with a study center

  • Peter Verdonk

    Deurne, 2100
    Belgium

    Site Not Available

  • Elizaveta Kon

    Milan, 20089
    Italy

    Site Not Available

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