- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05322005
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giulia Cattarini Mastelli, Dr.ssa
- Phone Number: Tel. (+39) 0184 5111 21
- Email: dirmed@mastelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
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 |
Intervention / Treatment |
---|---|
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
|
Arthroscopic procedure
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.
|
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
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
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:
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizaveta Kon, Prof., Plastic surgery IRCCS Humanitas
- Principal Investigator: Peter Verdonk, Prof., Monica Ziekenhuizen Antwerpen en Deurne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DDM22M
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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