Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study

Abstract

Background: Pronolis®HD mono 2.5% is a novel, one-shot, high-density sterile viscoelastic solution, recently available in Spain, which contains a high amount of intermediate molecular weight hyaluronic acid (HA), highly concentrated (120 mg in 4.8 mL solution: 2.5%). The objective of the study was to analyze the efficacy and safety of this treatment in symptomatic primary knee osteoarthritis (OA).

Methods: This observational, prospective, multicenter, single-cohort study involved 166 patients with knee OA treated with a single-shot of Pronolis®HD mono 2.5% and followed up as many as 24 weeks.

Results: Compared with baseline, the score of the Western Ontario and McMaster Universities Arthritis Osteoarthritis Index (WOMAC) pain subscale reduced at the 12-week visit (primary endpoint, median: 9 interquartile range [IQR]: 7-11 versus median: 4; IQR: 2-6; p < 0.001). The percentage of patients achieving > 50% improvement in the pain subscale increased progressively from 37.9% (at 2 weeks) to 66.0% (at 24 weeks). Similarly, WOMAC scores for pain on walking, stiffness subscale, and functional capacity subscale showed significant reductions at the 12-week visit which were maintained up to the 24-week visit. The EuroQol visual analog scale score increased after 12 weeks (median: 60 versus 70). The need for rescue medication (analgesics/nonsteroidal anti-inflammatory drugs) also decreased in all post-injection visits. Three patients (1.6%) reported local adverse events (joint swelling) of mild intensity.

Conclusions: In conclusion, a single intra-articular injection of the high-density viscoelastic gel of HA was associated with pain reduction and relief of other symptoms in patients with knee OA.

Trial registration: ClinicalTrial# NCT04196764.

Keywords: High-density viscoelastic gel; Hyaluronic acid; Intra-articular injection; Knee osteoarthritis; WOMAC.

Conflict of interest statement

Authors declare: JC has received financial support from Procare Health for training sessions. DK has received research grants from Procare Health. LT declares no conflict of interest. JM has received financial support from Procare Health for scientific lectures and attending to medical congresses.

© 2022. The Author(s).

Figures

Fig. 1

Different available treatments for knee osteoarthritis

Fig. 2

Flowchart of patients and design of the study

Fig. 3

Boxplots showing the evolution of WOMAC scores WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index The rhombus shows the mean value of the respective subscale/item. Asterisks represent statistical differences (Wilcoxon test) found with respect to baseline (p < 0.001). Data for WOMAC joint stiffness and functional capacity subscales at the 2-week visit were no collected.

Fig. 4

Evolution of need for rescue medication during the post-injection visits McNemar test: *p = 0.007, **p < 0.001