Evidence map›Paper›PMID 31511072›Full record

ArticleBMC musculoskeletal disorders2019

Biocompatibility study of different hyaluronan products for intra-articular treatment of knee osteoarthritis.

Keiji Yoshioka, Madoka Katayama, Takeo Nishiyama, Kohei Harada, Sawako Takeshita, Yuji Kawamata

Open access · goldAbstract read
In one paragraph

Article in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Keiji YoshiokaCentral Research Laboratory, SEIKAGAKU CORPORATION, 1253, Tateno 3-chome, Higashiyamato-shi, Tokyo, 207-0021, Japan. keiji.yoshioka@seikagaku.co.jp.
Madoka KatayamaCentral Research Laboratory, SEIKAGAKU CORPORATION, 1253, Tateno 3-chome, Higashiyamato-shi, Tokyo, 207-0021, Japan.
Takeo NishiyamaCMC Laboratory, Tokyo, Japan.
Kohei HaradaCentral Research Laboratory, SEIKAGAKU CORPORATION, 1253, Tateno 3-chome, Higashiyamato-shi, Tokyo, 207-0021, Japan.
Sawako TakeshitaMedical Science Liaison Unit, Seikagaku Corporation, Tokyo, Japan.
Yuji KawamataCentral Research Laboratory, SEIKAGAKU CORPORATION, 1253, Tateno 3-chome, Higashiyamato-shi, Tokyo, 207-0021, Japan.
Seikagaku Corporation (Japan) · JPJapan BCG Laboratory · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntra-articular (IA) injection of hyaluronic acid (HA) (IA-HA) is a well-recognized treatment option for pain associated with symptomatic knee osteoarthritis (OA). IA-HA products differ in their HA content, molecular weight, cross-linking, and source of HA. These differences are assumed to affect the biocompatibility of the IA-HA products once injected inside the knee joint.

methodsIn the present study, we investigated the biocompatibility of three multiple-injection IA-HA products available in the global market. These included SUPARTZ FX™, a medium range molecular weight HA derived from rooster comb (Avian-HA); ORTHOVISC®, a high range molecular weight HA obtained through biological fermentation (Bio-HA); and SYNVISC®, a high molecular weight cross-linked hyaluronan derived from rooster comb (Avian-CL-HA). Rabbit knee joint tissues were histologically and biochemically examined after IA injection of the products. Furthermore, we compared the amounts of impurities in the IA-HA products.

resultsIA injection of Avian-CL-HA into rabbit knee joints induced the aggregation of inflammatory cells, infiltration of eosinophils, and an increase in the number of cells in the synovial fluid. However, these effects were not seen in the Avian-HA and Bio-HA groups. The residual protein content and the contaminant levels of bacterial endotoxins were below the limit of quantitation in all HA products. Avian-CL-HA contained relatively a large amount of (1 → 3)-β-D-glucan, but this was below the lower limit of quantification in the other HA products.

conclusionsThe present results clearly demonstrate that the biocompatibility of Avian-HA is comparable to that of Bio-HA, and they were both considered to have a favorable safety profile for the treatment of symptomatic OA of the knee. However, immunostimulatory activity was observed after injection of Avian-CL-HA: this might be a result of its unique cross-linking structure and/or the considerable amount of (1 → 3)-β-D-glucan impurity present in the formulation.

Indexed as

AnimalsDrug ContaminationHumansHyaluronic AcidInjections, Intra-ArticularKnee JointMaleMaterials TestingModels, AnimalOsteoarthritis, KneeRabbitsSynovial FluidViscosupplementsHyaluronic AcidhylanorthoviscViscosupplements(1 → 3)-β-D-glucanAvianBiocompatibilityFermentationHyaluronan

Identifiers

PMID31511072
PMCPMC6739973
OpenAlexW2972376939

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.