Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid (PNHA1401)

Istituto Ortopedico Rizzoli

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Hyaluronic acid - HA - Ialart

Device: Polynucleotide - PNHA - Newart

Study type

Interventional

Funder types

Other

Identifiers

NCT02417610

22/14

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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