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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Meniscus Tear
- Sponsor
- Mastelli S.r.l
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The change of the International Knee Documentation Committee (IKDC Questionnaire)(24 months)
- The change of the radiological assessment of the cartilage by a 5-points Likert scale(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).(24 months)
- AE and device deficiencies Reporting(24 months)