Meniscus TearNCT05322005
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
A study testing partial meniscectomy and Condrotide® (polynucleotides gel: class III medical device) in people with Meniscus Tear and Meniscus Lesion, run by Mastelli S.r.l at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus Tear, Meniscus Lesion
- What is being tested?
- partial meniscectomy and Condrotide® (polynucleotides gel: class III medical device)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Oct 2020to 27 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- Meniscus Tear, Meniscus Lesion
- Being tested
- partial meniscectomy, Condrotide® (polynucleotides gel: class III medical device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial meniscectomyProcedure or surgery
Arthroscopic procedure
Condrotide® (polynucleotides gel: class III medical device)Device
Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: augmentation to surgery | Experimental | 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 Receives: Procedure: partial meniscectomy; Device: Condrotide® (polynucleotides gel: class III medical device) |
| Arm B: conservative treatment | Experimental | The patients are going to receive three injections session (polynucleotide gel) performed with a time interval of 2 weeks. Receives: Device: Condrotide® (polynucleotides gel: class III medical device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured
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.
Measured: 24 months (end of follow up)
Secondary outcomes (4)
The change of the radiological assessment of the cartilage by a 5-points Likert scale
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).
Measured: 24 months
The change of the International Knee Documentation Committee (IKDC Questionnaire)
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.
Measured: 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).
The Tegner activity scale is a one-item score evaluating work and sports activities on a scale of 0 to 10. Zero represents disability.
Measured: 24 months
AE and device deficiencies Reporting
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 Oct 2020
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mastelli S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizaveta Kon, Prof., Principal investigator, Plastic surgery IRCCS HumanitasPeter Verdonk, Prof., Principal investigator, Monica Ziekenhuizen Antwerpen en Deurne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322005
- Sponsor's protocol ID
- DDM22M
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05322005
- Acronym / sponsor ID
- DDM22M
- Conditions
- Meniscus Tear, Meniscus Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mastelli S.r.lIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: augmentation to surgery | Experimental | Procedure: partial meniscectomy, Device: Condrotide® (polynucleotides gel: class III medical device)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 |
| Arm B: conservative treatment | Experimental | Device: Condrotide® (polynucleotides gel: class III medical device)The patients are going to receive three injections session (polynucleotide gel) performed with a time interval of 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partial meniscectomyArthroscopic procedure | Procedure or surgery | Arm A: augmentation to surgery |
| Condrotide® (polynucleotides gel: class III medical device)Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection | Device | Arm A: augmentation to surgery, Arm B: conservative treatment |
Primary outcome
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.
4 secondary outcomes
The change of the radiological assessment of the cartilage by a 5-points Likert scale
Time frame: 24 months
The change of the International Knee Documentation Committee (IKDC Questionnaire)
Time frame: 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
AE and device deficiencies Reporting
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizaveta Kon, Prof. principal investigator
Plastic surgery IRCCS Humanitas
Peter Verdonk, Prof. principal investigator
Monica Ziekenhuizen Antwerpen en Deurne
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial meniscectomy and Condrotide® (polynucleotides gel: class III medical device) in people with Meniscus Tear and Meniscus Lesion, run by Mastelli S.r.l at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured (time frame: 24 months (end of follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.