Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Polynucleotide - PNHA - Newart; Hyaluronic acid - HA - Ialart
Intervention type(s): Device; Device
Intervention description(s): gel polynucleotides and hyaluronic acid; Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polynucleotide; Hyaluronic acid; Intra articular injection