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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.
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:
FOLLOW UP:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polynucleotide - PNHA - Newart | Experimental | 50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid |
|
| Hyaluronic acid - HA - Ialart | Active Comparator | 50 patients will be enrolled and treated with three weekly injections of hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polynucleotide - PNHA - Newart | Device | gel polynucleotides and hyaluronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dante Dallari, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34511091 | Derived | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Hyaluronic acid - HA - Ialart | Device | Hyaluronic acid |
|
| 6 months |
| Synovial fluid analysis | Morphological analysis and blood white cell count | 3 weeks |
| Growth factor contained in synovial fluid determinations | Total protein content, IL1beta, IL6, IL8, TNFalpha, MMP1 | 3 weeks |