Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.

Detailed Description
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This study aims to compare effectiveness of the treatment with intra-articular administration of collagen-PVP versus hylan GF 20, using the International Knee Documentation Committee (IKDC) score, 6 months after treatment. Hypothesis to test is: If effectiveness of intra-articular collagen-PVP is not lower than hylan GF 20 treatment in knee osteoarthritis subjects, then, statistically significant difference would not exist in IKDC score mean increase among treatment groups, after six months.

Official Title
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Efficacy Evaluation of Intraarticular Collagen-polyvinyl Pyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

Conditions
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Knee Osteoarthritis, Gonarthrosis

Intervention / Treatment
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* Drug: Collagen-PVP
* Device: Hylan G-F 20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 40 and 80 years old Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale). Pain intensity (MOS Pain Severity Scale) greater than 40. Subject able to understand, co-operative and reliable. Written informed consent. Exclusion Criteria: Acute arthritis in the knee. Ongoing anticoagulant therapy. Skin infection at the injection site. Systemic or intraarticular (target knee) corticosteroids in the past 3 months. Viscosupplementation (target knee) in the past year Arthroscopy/osteotomy/surgery in the past 5 months (target knee). Any surgery scheduled in the next 6 months Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia). Severe varus/valgus deformity (>15°). Frontal deformity greater than 20 degrees History of allergy or hypersensitivity to hyaluronic acid or avian proteins History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants in one group receive drug A (Hylan G-F20) in parallel to participants in the other group, who receive drug B (Collagen-PVP).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen-PVP<br>Collagen-polyvinyl pyrrolidone (collagen-PVP). | Drug: Collagen-PVP<br>* Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days)<br>* Other names: Fibroquel;|
| Active Comparator: Hylan G-F 20<br>Hylan G-F 20. | Device: Hylan G-F 20<br>* Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)<br>* Other names: Synvisc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC). | Change from Baseline in International Knee Documentation Committee (IKDC) subjective score at 6 months. The IKDC subjetive form is a patient-reported outcome, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).The IKDC is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (add the score for each item and divide by the maximum possible). The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms. | Evaluation will be conducted at Baseline and 6 months after first infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity | Change from Baseline in Pain Intensity score (MOS Pain severity scale) at 6 months. The Medical Outcomes Study (MOS) Pain Severity Scale is a 5-item scale to assess pain intensity (average and at the most), frequency, and duration over the last 7 days. Scores range from 0-100; higher score indicates more pain | Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration | 
| Change in quality of life: EQS-5D | Change from Baseline in quality of life (EQS-5D) score at 6 months. | Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration | 
| Changes in Urine Collagen Type II C-telopeptide Fragments | Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months | Evaluation will be conducted at Baseline, and 6 months after first infiltration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Intraarticular Injections, Viscosupplementations, Type I Collagen, Patient Outcome Assessment, Patient Reported Outcome Measures