N/A
N=65
Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT06429319 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in the Total WOMAC Score (WOMAC-T) — 649.80; 1091.70; 767.47; 293.60 score on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Research Centre BIOFORM
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total WOMAC Score (WOMAC-T) |
649.80; 1091.70; 767.47; 293.60; 376.00; 260.29 | 0.004 sig |
| SECONDARY Change in the WOMAC Pain Score (WOMAC-A) |
125.80; 211.02; 158.18; 60.00; 67.26; 44.24 | — |
| SECONDARY Change in the WOMAC Stiffness (WOMAC-B) Score |
78.60; 95.23; 69.94; 26.00; 30.16; 26.29 | — |
| SECONDARY Change in the WOMAC Physical Function (WOMAC-C) Score |
445.40; 785.44; 539.35; 207.60; 278.58; 189.76 | — |
| SECONDARY Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS) |
47.20; 58.63; 64.35; 30.80; 17.33; 9.47 | 0.030 sig |
| SECONDARY Patient's Assessment of the Treatment Efficacy |
0; 0; 0; 0; 0; 0 | <0.001 sig |
| SECONDARY Investigator's Assessment of the Treatment Efficacy |
0; 0; 0; 0; 0; 0 | 0.018 sig |
| SECONDARY Total Number of Paracetamol Tablets Taken |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Total Number of NSAID Tablets Taken |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The JSN in the Target Knee |
-0.02; -0.00; 0.02 | 0.010 sig |
Summary
The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.
Eligibility Criteria
Inclusion Criteria
- Men and women over 50 years of age;
- Provision of signed informed consent form;
- Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age >50 years, stiffness 360 µmol/l;
- Intra-articular injection into the target knee joint:
- hyaluronates - within 12 months prior to patient enrollment in the study;
- other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
- glucocorticoids - within 1 month before enrollment in the study;
- NSAIDs - intra-articular injection at any time in the history.
- Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
- Effusion in the target joint;
- The presence of inflammation or infection in the target joint, synovitis;
- The need for continuous use of glucocorticoids in any dosage form;
- Use of paracetamol within 48 hours prior to Visit 0;
- A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
- Severe liver disease, defined as an increase in one of the following: ALT, AST, alkaline phosphatase, total bilirubin, GGT more than 3 times the upper limit of normal;
- Kidney disease with a glomerular filtration rate as assessed by the Cockcraft-Gault formula less than 60 mL/min/1.73 m2 (stages III-V chronic kidney disease [CKD]);
- Clinical manifest coxarthrosis;
- Severe decompensated chronic or acute diseases and other conditions or other causes that, in the investigator's opinion, may prevent the patient from participating in the study or affect the study results ;
- Participation in any other clinical trial except that IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the OLE.
Data sourced from ClinicalTrials.gov (NCT06429319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.