Evidence map›Paper›PMID 25889322›Full record

Trial reportArthritis research & therapy2015

Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz.

Heng Zhang, Ke Zhang, Xianlong Zhang, Zhenan Zhu, Shigui Yan, Tiansheng Sun, Ai Guo, John Jones, R Grant Steen, Bin Shan and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01295580 (A Multicenter, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial With Non-inferiority Comparison to Evaluate Efficacy and Safety of Intra-articular Injection of DUROLANE® vs. ARTZ® in Treatment of Knee Osteoarthritis), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 9% 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.

NCT01295580 nacompletednot on this map

A Multicenter, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial With Non-inferiority Comparison to Evaluate Efficacy and Safety of Intra-articular Injection of DUROLANE® vs. ARTZ® in Treatment of Knee Osteoarthritis

TypeinterventionalSponsorBioventus LLCRan2011 to 2012Enrolled349ConditionsKnee OsteoarthritisArmsARTZ, DUROLANE
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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  8. 9. Chronic knee pain.Pain practice : the official journal of World Institute of Pain · 2025
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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

12 authors at 5 institutions in 2 countries.

Heng ZhangArthritis Clinic & Research Center, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. 469325342@qq.com.
Ke ZhangDepartment of Orthopedics, Peking University Third Hospital, Beijing, China. zhangke60@medmail.com.cn.
Xianlong ZhangDepartment of Orthopedics, Shanghai 6th People's Hospital, Shanghai, China. zxl40@vip.sina.com.
Zhenan ZhuDepartment of Orthopedics, Shanghai 9th People's Hospital, Shanghai, China. zhuzhenan2006@126.com.
Shigui YanDepartment of Orthopedics, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang Province, China. zrjwsj@zju.edu.cn.
Tiansheng SunDepartment of Orthopedics, Beijing Military General Hospital, Beijing, China. suntiansheng_@163.com.
Ai GuoDepartment of Orthopedics, Beijing Friendship Hospital, Beijing, China. guoaij@yahoo.com.cn.
John JonesBioventus LLC, Durham, NC, USA. John.Jones@bioventusglobal.com.
R Grant SteenBioventus LLC, Durham, NC, USA. Grant.Steen@bioventusglobal.com.
Bin ShanTigerMed Consulting Co., Ltd, Beijing, China. bin.shan@tigermed.net.
Jenny ZhangTigerMed Consulting Co., Ltd, Beijing, China. jenny.zhang@tigermed.net.
Jianhao LinArthritis Clinic & Research Center, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. linjianhao@pkuph.edu.cn.
Peking University · CNDurham University · GBBeijing Friendship Hospital · CNThe Military General Hospital of Beijing PLA · CNZhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntra-articular injection of hyaluronic acid (HA) is often used as therapy for knee osteoarthritis because it is less expensive and less aggressive than total knee replacement. Therefore, it is important to document whether HA is safe and efficacious. We tested whether single and multiple injection viscosupplementation with HA is associated with clinically meaningful pain relief in a new randomized clinical trial (RCT). Our objective was to compare safety and efficacy of intra-articular HA in two formulations: one 3.0 ml injection of Durolane versus five 2.5 ml injections of Artz for the treatment of knee osteoarthritis pain.

methodsPatients (N=349) from the People's Republic of China were randomized to treatment (Durolane=175, Artz=174). The Durolane group received a 3.0 ml injection at week 0 (baseline), with sham skin punctures at weeks 1, 2, 3, and 4. The Artz group received one 2.5 ml injection at each of the same time points. The primary assessment tool was the Likert-type Western Ontario and McMaster University (WOMAC) pain scale at weeks 0, 6, 10, 14, 18, and 26. Secondary assessments were WOMAC physical function, knee stiffness, and global self-assessment, at identical time points. Statistically-controlled analyses were non-inferiority of Durolane over 18, then over 26 weeks, with a priori non-inferiority defined as 8% of the relevant scale. Acetaminophen was permitted as rescue analgesia and all adverse events (AEs) were recorded.

resultsOverall study retention was excellent; 332 patients (95.1%) completed 18 weeks and 319 (91.4%) completed 26 weeks, with no significant retention difference between treatment arms. All variables met non-inferiority criteria over 18 and 26 weeks. Efficacy response in both arms was >90%. Treatment-related AEs were 9.8% (17/174) for Artz and 13.1% (23/175) for Durolane.

conclusionsA single injection of Durolane is non-inferior to 5 injections of Artz over 18 and 26 weeks for pain, physical function, global self-assessment, and knee stiffness. Both treatments were efficacious, safe, and well tolerated.

trial registrationClinicalTrials.gov NCT01295580 . Registered 11 February 2011.

Indexed as

Adjuvants, ImmunologicAdultAgedDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansHyaluronic AcidInjections, Intra-ArticularKnee JointMaleMiddle AgedOsteoarthritis, KneeProspective StudiesTreatment OutcomeAdjuvants, ImmunologicHyaluronic Acid

Identifiers

PMID25889322
PMCPMC4391669
OpenAlexW2112990569

What OpenQuestion holds

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Registered trials

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.