Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid

Study Overview
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Brief Summary
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The purpose of the study is to assess the validity of the polynucleotide within the intra articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic acid, the most commonly used.

Detailed Description
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This study is double-blind, controlled, randomized.The aim of the study is to evaluate the efficacy, safety and tolerability of polynucleotides and hyaluronic acid gel (PNHA, class III medical device) for intra-articular infiltration in treating pain in osteoarthritis (OA) patients knee. This study will involve patients with osteoarthritis who comply with the inclusion and exclusion criteria. One hundred patients between the ages of 45 and 70 will be enrolled in the study and randomized to receive one of the following treatment groups: Group A) Polynucleotides and Hyaluronic Acid (PNHA) Group B) Hyaluronic Acid (HA) The treatment will be administered through intra-articular infiltration, a weekly infiltration in the affected knee, for a total of 3 infiltrations (T0, T1 and T2). The use of non-steroidal anti-inflammatory drugs (NSAIDs) was permitted, but the use of paracetamol 1 cp 1000 mg every 12 hours, or Meloxicam 15 mg a tablet after meals every 12 hours, was recommended. In case of grug taking: the number of days when the patient used NSAIDs, the commercial name and the NSAID dosage used were reported in the CRF. Study visit: T0 start study: inclusion in the clinical trial and assignment of the randomization number; radiography; clinical study start-up evaluation; fill in the WOMAC questionnaire; infiltration No. 1. T 1 after 1 week from the beginning of the study: infiltration No. 2. T 2 after 2 weeks from the beginning of the study (end of treatment): infiltration No. 3. FOLLOW UP: T 3 after 2 months from the beginning of the study: clinical evaluation; fill in the WOMAC questionnaire. T 4 after 6 months from the start of the study: clinical evaluation; fill in the WOMAC questionnaire. T 5 after 1 year from the beginning of the study: clinical evaluation; fill in the WOMAC questionnaire. T 6 after 2 years from the beginning of the study: radiography; clinical evaluation; fill in the WOMAC questionnaire. At T6 visit, the patient completed the study. A 24-month study period is calculated for each patient. Any adverse event that occurred during the study period was recorded.

Official Title
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Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid to Viscosupplementation With Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee. Randomized, Double-blind, Controlled Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Polynucleotide - PNHA - Newart
* Device: Hyaluronic acid - HA - Ialart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 50 and 75 years Patients informed consent Knee OA (Osteoarthritis) (ACR classification) with a Kellgren Laurence from 1 to 4 Knee pain from arisen at least 2 months BMI lower than 40 Exclusion Criteria: Pregnancy or lactation Severe systemic disorders History of drug abuse or alcoholism Hypersensibility to Hyaluronic acid or Polynucleotide No previous intra articular infiltration (from 3 months) No steroidal or anticoagulant systemic therapy from one month Knee articular deformity Patients affected by rheumatoid arthritis or other inflammatory articular pathologies and hematological disorders Focal skin lesion in the anatomical site of injections

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polynucleotide - PNHA - Newart<br>50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid | Device: Polynucleotide - PNHA - Newart<br>* gel polynucleotides and hyaluronic acid<br>|
| Active Comparator: Hyaluronic acid - HA - Ialart<br>50 patients will be enrolled and treated with three weekly injections of hyaluronic acid | Device: Hyaluronic acid - HA - Ialart<br>* Hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | The WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS (Knee society score) | The Knee Society Score it comprises two parts, the first addressing pain, stability and range of movement. The second part examines function, with particular reference to walking distance and stair climbing. Maximum scores of 100 are possible in each section, consider a negitive outcome as zero. Grading for the knee Society Score Excellent: Score 80-100 Good: Score 70-79 Fair: Score 60-69 Poor: Score below 60. A Knee Society Score questionnaire will be used in the study. | 6 months | 
| Synovial fluid analysis | Morphological analysis and blood white cell count | 3 weeks | 
| Growth factor contained in synovial fluid determinations | Total protein content, IL1beta, IL6, IL8, TNFalpha, MMP1 | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polynucleotide, Hyaluronic acid, Intra articular injection