OsteoarthritisPNHA1401NCT02417610
Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid
A study testing Polynucleotide - PNHA - Newart and Hyaluronic acid - HA - Ialart in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Polynucleotide - PNHA - Newart and Hyaluronic acid - HA - Ialart
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Polynucleotide - PNHA - Newart, Hyaluronic acid - HA - Ialart
- Keywords
- Polynucleotide, Hyaluronic acid, Intra articular injection
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polynucleotide - PNHA - NewartDevice
gel polynucleotides and hyaluronic acid
Hyaluronic acid - HA - IalartDevice
Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Polynucleotide - PNHA - Newart | Experimental | 50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid Receives: Device: Polynucleotide - PNHA - Newart |
| Hyaluronic acid - HA - Ialart | Active comparator | 50 patients will be enrolled and treated with three weekly injections of hyaluronic acid Receives: Device: Hyaluronic acid - HA - Ialart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
KSS (Knee society score)
The Knee Society Score it comprises two parts, the first addressing pain, stability and range of movement. The second part examines function, with particular reference to walking distance and stair climbing. Maximum scores of 100 are possible in each section, consider a negitive outcome as zero.
Grading for the knee Society Score
Excellent: Score 80-100 Good: Score 70-79 Fair: Score 60-69 Poor: Score below 60. A Knee Society Score questionnaire will be used in the study.
Measured: 6 months
Synovial fluid analysis
Morphological analysis and blood white cell count
Measured: 3 weeks
Growth factor contained in synovial fluid determinations
Total protein content, IL1beta, IL6, IL8, TNFalpha, MMP1
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carubbi, Istituto Ortopedico Rizzoli
- Investigators
- Dante Dallari, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417610
- Sponsor's protocol ID
- 22/14
- Acronym
- PNHA1401
- Status last verified
- Dec 2017
- First submitted
- 17 Feb 2015
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34511091
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02417610
- Acronym / sponsor ID
- PNHA1401 / 22/14
- Conditions
- Osteoarthritis
- Keywords
- Polynucleotide, Hyaluronic acid, Intra articular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polynucleotide - PNHA - Newart | Experimental | Device: Polynucleotide - PNHA - Newart50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid |
| Hyaluronic acid - HA - Ialart | Active comparator | Device: Hyaluronic acid - HA - Ialart50 patients will be enrolled and treated with three weekly injections of hyaluronic acid |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polynucleotide - PNHA - Newartgel polynucleotides and hyaluronic acid | Device | Polynucleotide - PNHA - Newart |
| Hyaluronic acid - HA - IalartHyaluronic acid | Device | Hyaluronic acid - HA - Ialart |
Primary outcome
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 6 months
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.
3 secondary outcomes
KSS (Knee society score)
Time frame: 6 months
Synovial fluid analysis
Time frame: 3 weeks
Growth factor contained in synovial fluid determinations
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Derived from this study: PubMed 34511091Stagni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dante Dallari, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polynucleotide - PNHA - Newart and Hyaluronic acid - HA - Ialart in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.