Evidence map›Paper›PMID 28535076›Full record

Trial reportCartilage2018

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.

Laszlo Hangody, Robert Szody, Piotr Lukasik, Wojciech Zgadzaj, Endre Lénárt, Eva Dokoupilova, Daniela Bichovsk, Agnes Berta, Gabor Vasarhelyi, Andrea Ficzere and 3 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cartilage, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 54 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 7 pooled it
5.5field-weighted citation impact, top 4% 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.

NCT01891396 nacompletednot on this map

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

TypeinterventionalSponsorAnika Therapeutics, Inc.Ran2013 to 2014Enrolled368ConditionsKnee OsteoarthritisArmsHyaluronic Acid and TH (Cingal®), Hyaluronic Acid (Monovisc®), Saline
NCT05408065 narecruitingnot on this mapstarted 2022, after this paper: background citation

A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2022 to 2026Enrolled84ConditionsInfiltration, Shoulder OsteoarthritisArmsTriamcinolone Hexacetonide and hyaluronic acid, Triamcinolone Hexacetonide
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 7 syntheses or guidelines pooled it, 79 citations in OpenAlex.

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  15. The Challenges of Local Intra-Articular Therapy.Medicina (Kaunas, Lithuania) · 2024
    Review
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  19. [Evaluation of early effectiveness of local infiltration anesthesia with compound betamethasone in total knee arthroplasty].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2024
    Article
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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

13 authors at 7 institutions in 4 countries.

Laszlo Hangody1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
Robert Szody2 Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic, Budapest, Hungary.
Piotr Lukasik3 NZOZ Medi SPATZ, Gilwice, Poland.
Wojciech Zgadzaj4 ARTIMED Niepubliczny Zakład Opieki Zdrowotnej, Kielce, Poland.
Endre Lénárt5 Jutrix Medical LLC, Kecskémet, Hungary.
Eva Dokoupilova6 Medical Plus s.r.o., Uherske Hradiste, Czech Republic.
Daniela Bichovsk7 Consultative Outpatients' Medical Office for Rheumatologic Diseases, Sofia, Bulgaria.
Agnes Berta1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
Gabor Vasarhelyi1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
Andrea Ficzere1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
György Hangody1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
Gary Stevens8 Dynastat Biostatistical Consulting, Austin, TX, USA.
Miklos Szendroi9 Semmelweis Egyetem Orthopaedic Clinic, Budapest, Hungary.
Uzsoki Hospital · HUBiostatistical Consulting (United States) · USBuda Health Center · HUMedical Plus · CZMeditest · PLNZOZ Medi-Spatz · PLSemmelweis University · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.

designThis multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.

resultsA total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.

conclusionsCingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

Indexed as

AgedAnti-Inflammatory AgentsCombined Modality TherapyDouble-Blind MethodFemaleHumansHyaluronic AcidInjections, Intra-ArticularKnee JointMaleMiddle AgedOsteoarthritis, KneeTreatment OutcomeTriamcinolone AcetonideViscosupplementsAnti-Inflammatory AgentsHyaluronic AcidTriamcinolone Acetonidetriamcinolone hexacetonideViscosupplementsclinical trialdiagnosisgeneralintraarticular deliveryjoint involvedkneeosteoarthritistherapeutic delivery

Identifiers

PMID28535076
PMCPMC6042027
OpenAlexW2619901099

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.