INJECTION CLINICAL LIBRARY

Welcome to our clinical library for managing arthritis with injection therapies. We’re adding more evidence all the time. Get in touch if you’re looking for something specific that we don’t have on this page

Injection Product Pages

Comparative Data

We compared all the data points from each leading HA injection to Cingal and Monovisc from the above study.

The data referenced from the competitor products is taken from their quoted trials on their marketing and websites.

Other Injections shaded areas include: Ostinel Plus, Durolane, SynviscOne, GelOne, Hyalagan

References. (1) Hangody L., et al. Cartilage 2017 May. DOI: 10.1177/1947603517703. (2) Durolane Knee PMA (P060013) Summary of Safety and Effectiveness Data. (3) Synvisc-One (P940015/S012) Summary of Safety and Effectiveness Data. (4) Takamura, J, et al. Clin Med Ins: Arth Musc Dsrdr, V11: 1–6, 2018. (5) Borrás-Verdera, A, et al. Rev Esp Cir Ortop Traumatol. 2012;56(4):274-280

Key CINGAL clinical data points

CINGAL data was taken from the study: Phase 3, ’13-01′, a randomized, double-blind, placebo-controlled, active comparator Phase III study.

The evaluation was initially published in ‘Cartilage’ in 2017 with the chief investigator Lazlo Hangody. You can download the paper here:

Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial

Cingal showed highly statistical improvements compared to saline at all secondary endpoints at 26 weeks within this study.

Other key data points from this study are;

•59% reduction in WOMAC Pain at 1 Week

•72% reduction in WOMAC Pain at 26 Weeks

•89% responder rate in the OMERACT-OARSI Responder Index at week 1 (p = 0.0161)

•92% responder rate in the OMERACT-OARSI Responder Index through week 26 (p = 0.0100)

Key MONOVISC clinical data points

This data was taken from the same study as above, by Lazlo Hangody. A randomised, double-blind, Level 1 study.

Here you can see Monovisc (as plotted on the graph above) carries through a greater pain reduction to the 26 week mark than any other pure hyaluronic acid injection product.

Cingal as stated above achieved 72% reduction on pain at 26 weeks.

A key part of the Monovisc clinical data is the repetition of the results across more than one study. Stephanie C. Petterson et al evaluated Monovisc in a multicentre evaluation in 2017. You can download the paper here:

Single intra-articular injection of lightly cross-linked hyaluronic acid reduces knee pain in symptomatic knee osteoarthritis: a multicenter, double-blind, randomized, placebo-controlled trial

Conclusion from this study

“Monovisc™, a single-injection intra-articular HA device, is a safe and effective treatment for providing a clinically meaningful reduction in knee pain within 2 weeks. The results of this study support the use of a single injection of hyaluronic acid (Monovisc™) for patients with symptomatic knee OA in patients older than 45 years, as a safe and effective alternative for patients who may want an alternative treatment modality or may not be candidates for partial or total knee replacement.”

Reported Adverse Events

Monovisc and Cingal have the lowest adverse events reported in their safety and efficacy studies than any other injectable for OA. Note the reported rates below are for minor issues like short term skin irritation. There have been 0% major adverse events reports.

In the post approval study of Monovisc ‘A Symptomatic Treatment of Osteoarthritis’ which was a white paper, 2.5% experienced mild injection site events.
In the Hangody Study mentioned above, 2% for Cingal experienced mild injection site events
Neither Cingal, Monovisc or Orthovisc have had any reported serious adverse events.

Overall in every study, the conclusion remains that all three are extremely safe options in the reduction of pain for the arthritic joint.

The importance of molecular weight

The synthesis of hyaluronic acid by human synovial fibroblasts is influenced by the nature of the hyaluronate in the extracellular environment.

Rheumatol Int. 1987; 7(3):113-22. Smith MM, Ghosh P.

Abstract

Various cell lines of human synovial fibroblasts derived from synovium obtained at the time of biopsy or total joint-replacement surgery have been established. The synthesis of 3H-labelled hyaluronic acid (HA) in these cells has been determined, and the effects of adding HA of varying molecular size to the cultured cells examined. The results obtained clearly show that the in vitro synthesis of HA by these cells is influenced by the concentration and molecular weight (MW) of the HA in their extracellular environment. Synovial fibroblasts derived from an osteoarthritic joint demonstrated the most marked response on exposure to exogenous HA, showing a stimulation of HA synthesis with preparations of weight-average molecular weight (Mw) greater than 5 X 10(5) in a concentration dependent manner. HA preparations with Mw less than 5 X 10(5) showed little or no effect except at high concentrations where a suppression of biosynthesis was observed. A model to explain these findings is proposed.

Full paper

Synovitis in osteoarthritis: current understanding with therapeutic implications

Abstract:

Modern concepts of osteoarthritis (OA) have been forever changed by modern imaging phenotypes demonstrating complex and multi-tissue pathologies involving cartilage, subchondral bone and (increasingly recognized) inflammation of the synovium. The synovium may show significant changes, even before visible cartilage degeneration has occurred, with infiltration of mononuclear cells, thickening of the synovial lining layer and production of inflammatory cytokines. The combination of sensitive imaging modalities and tissue examination has confirmed a high prevalence of synovial inflammation in all stages of OA, with a number of studies demonstrating that synovitis is related to pain, poor function and may even be an independent driver of radiographic OA onset and structural progression. Treating key aspects of synovial inflammation therefore holds great promise for analgesia and also for structure modification. This article will review current knowledge on the prevalence of synovitis in OA and its role in symptoms and structural progression, and explore lessons learnt from targeting synovitis therapeutically.

Full Paper