Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid
NCT ID: NCT02417610
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2014-09-30
2017-07-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Polynucleotide - PNHA - Newart
50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid
Polynucleotide - PNHA - Newart
gel polynucleotides and hyaluronic acid
Hyaluronic acid - HA - Ialart
50 patients will be enrolled and treated with three weekly injections of hyaluronic acid
Hyaluronic acid - HA - Ialart
Hyaluronic acid
Interventions
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Polynucleotide - PNHA - Newart
gel polynucleotides and hyaluronic acid
Hyaluronic acid - HA - Ialart
Hyaluronic acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
75 Years
ALL
Yes
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Carubbi
MD
Principal Investigators
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Dante Dallari, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Ortopedico Rizzoli
Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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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.
Other Identifiers
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22/14
Identifier Type: -
Identifier Source: org_study_id