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

August 7, 2025 updated by: Mastelli S.r.l

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Giulia Cattarini Mastelli, Dr.ssa
  • Phone Number: Tel. (+39) 0184 5111 21
  • Email: dirmed@mastelli.it

Study Locations

  • Belgium
      • Deurne, Belgium, 2100
        • Peter Verdonk
  • Italy
      • Milan, Italy, 20089
        • Elizaveta Kon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: augmentation to surgery
Patients will be surgically treated with partial meniscectomy combined with an intraarticular and intra-meniscal injection of polynucleotide gel, during an arthroscopic procedure. After 6 weeks the patients attend a second injection session, during an ambulatorial visit. At 8 weeks from the surgery the patients attend the third ambulatorial injection session
Procedure: partial meniscectomy
Arthroscopic procedure
Device: Condrotide® (polynucleotides gel: class III medical device)
Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection
Experimental: Arm B: conservative treatment
The patients are going to receive three injections session (polynucleotide gel) performed with a time interval of 2 weeks.
Device: Condrotide® (polynucleotides gel: class III medical device)
Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured
Time Frame: 24 months (end of follow up)

The change of overall KOOS score will be evaluated from baseline (V1) to 6 (V6), 12 (V7), and 24 (V8) months after treatment completion.

An improvement of 10 points in the score will be considered success.

The KOOS score assesses; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
24 months (end of follow up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of the radiological assessment of the cartilage by a 5-points Likert scale
Time Frame: 24 months
Likert scale scoring: 0=worsened; 1= not worsened or improved; 2= slightly improved; 3= improved; 4= very much improved). The articular cartilage and meniscal appearance change will be evaluated from baseline (V1) to 6 (V6), 12 (V7), 24 (V8) months after treatment completion (T0).
24 months
The change of the International Knee Documentation Committee (IKDC Questionnaire)
Time Frame: 24 months
Is a knee-specific patient-reported outcome measure. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
24 months
The change of the Tegner activity score from baseline (V1) to 3 (V5), 6 (V6), 12 (V7), 24 (V8) months after treatment completion (T0).
Time Frame: 24 months
The Tegner activity scale is a one-item score evaluating work and sports activities on a scale of 0 to 10. Zero represents disability.
24 months
AE and device deficiencies Reporting
Time Frame: 24 months

Will be evaluated:

  • number and typology of device- or procedure-related serious adverse events (SAEs)
  • the number and typology of all other adverse events (AEs) or SAEs;
  • the number and typology of device deficiencies (DD)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mastelli S.r.l

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Latis S.r.l.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizaveta Kon, Prof., Plastic surgery IRCCS Humanitas
  • Principal Investigator: Peter Verdonk, Prof., Monica Ziekenhuizen Antwerpen en Deurne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DDM22M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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