NCT02417610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

February 17, 2015

Last Update Submit

December 21, 2017

Conditions

Osteoarthritis

Keywords

PolynucleotideHyaluronic acidIntra articular injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • KSS (Knee society score)

    6 months

  • Synovial fluid analysis

    3 weeks

  • Growth factor contained in synovial fluid determinations

    3 weeks

Study Arms (2)

Polynucleotide - PNHA - Newart

EXPERIMENTAL

50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid

Device: Polynucleotide - PNHA - Newart

Hyaluronic acid - HA - Ialart

ACTIVE COMPARATOR

50 patients will be enrolled and treated with three weekly injections of hyaluronic acid

Device: Hyaluronic acid - HA - Ialart

Interventions

Polynucleotide - PNHA - NewartDEVICE

gel polynucleotides and hyaluronic acid

Polynucleotide - PNHA - Newart
Hyaluronic acid - HA - IalartDEVICE

Hyaluronic acid

Hyaluronic acid - HA - Ialart

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34511091DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dante Dallari, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 17, 2015

First Posted

April 15, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 20, 2017

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

IT(1)