Clinical trial NCT02417610: Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Polynucleotide
Hyaluronic acid
Intra articular injection
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 102
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: 6 months
Secondary outcomes:
measure: KSS (Knee society score)
timeFrame: 6 months
measure: Synovial fluid analysis
timeFrame: 3 weeks
measure: Growth factor contained in synovial fluid determinations
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Dante Dallari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stagni C, Rocchi M, Mazzotta A, Del Piccolo N, Rani N, Govoni M, Vivarelli L, Veronesi F, Fini M, Dallari D. Randomised, double-blind comparison of a fixed co-formulation of intra-articular polynucleotides and hyaluronic acid versus hyaluronic acid alone in the treatment of knee osteoarthritis: two-year follow-up. BMC Musculoskelet Disord. 2021 Sep 12;22(1):773. doi: 10.1186/s12891-021-04648-0.