N/A N=57

Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT06523491 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in the Total WOMAC Score (WOMAC-T) — 1137.13; 767.47; 1271.60; 445.33 score on a scale — p=0.00

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Research Centre BIOFORM
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Total WOMAC Score (WOMAC-T)	1137.13; 767.47; 1271.60; 445.33; 260.29; 616.00	0.00 sig
SECONDARY Change in the WOMAC Pain Score (WOMAC-A)	233.20; 158.18; 239.10; 80.93; 44.24; 103.90	—
SECONDARY Change in the WOMAC Stiffness (WOMAC-B) Score	96.17; 69.94; 101.00; 33.23; 26.29; 56.90	—
SECONDARY Change in the WOMAC Physical Function (WOMAC-C) Score	807.77; 539.35; 931.50; 331.17; 189.76; 455.20	—
SECONDARY Change in the 100-mm VAS Pain Score	61.23; 64.35; 59.50; 20.90; 9.47; 20.80	—

Summary

1-year follow-up of a randomized controlled trial with open-label extension to assess the long-term efficacy and safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis.

Eligibility Criteria

Inclusion criteria

The study included patients with KL grade 2-3 knee osteoarthritis who had completed study IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020.

Exclusion criteria

Declining participation in the survey Lost to follow-up

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06523491). 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.