Evidence map›Paper›PMID 21852252›Full record

Trial reportAnnals of the rheumatic diseases2011

A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project.

F Navarro-Sarabia, P Coronel, E Collantes, F J Navarro, A Rodriguez de la Serna, A Naranjo, M Gimeno, G Herrero-Beaumont, AMELIA study group

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 78 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 6 pooled it
10.3field-weighted citation impact, top 1% 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.

NCT00669032 nacompletednot on this map

Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee

TypeinterventionalSponsorTedec-Meiji Farma, S.A.Ran2003 to 2009Enrolled446ConditionsOsteoarthritis of the KneeArmsHyaluronic acid, Placebo
NCT03421054 nacompletednot on this mapstarted 2018, after this paper: background citation

Pilot, Open Non-controled Trial to Assess the Feasibility of Implementing Objective Parameters as Primary Endpoints in a Clinical Trial With Patients Affected by Knee Osteoarthritis

TypeinterventionalSponsorRiver Pharma S.r.l.Ran2018 to 2018Enrolled8ConditionsKnee OsteoarthritisArmspatients assuming nutraceutical containing HA
NCT03612986 nacompletednot on this mapstarted 2018, after this paper: background citation

Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis

TypeinterventionalSponsorRiver Pharma S.r.l.Ran2018 to 2019Enrolled72ConditionsKnee OsteoarthritisArmsSYALOX® 300 Plus, Placebo
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 6 syntheses or guidelines pooled it, 195 citations in OpenAlex.

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18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

F Navarro-SarabiaRheumatology Department, Hospital Universitario Virgen Macarena, Avda Doctor Fedriani 3, 41011 Sevilla, Spain. federico.navarro.sspa@juntadeandalucia.es
P Coronel
E Collantes
F J Navarro
A Rodriguez de la Serna
A Naranjo
M Gimeno
G Herrero-Beaumont
AMELIA study group
Meiji Pharma Spain · ESHospital de Sant Pau · ESHospital General Universitario de Elche · ESHospital Universitario de Gran Canaria Doctor Negrín · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen Macarena · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAMELIA (OsteoArthritis Modifying Effects of Long-term Intra-articular Adant) was designed to compare against placebo the efficacy and safety of repeated injections of hyaluronic acid (HA) and its effect on disease progression over 40 months.

methodsA multicentre, randomised, patient and evaluator-blinded, controlled study in 306 patients fulfilling American College of Rheumatology criteria for knee osteoarthritis, radiological grades II-III (Kellgren-Lawrence) and joint space width ≥ 2 mm. Patients received four cycles of five intra-articular HA or placebo injections with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. Osteoarthritis Research Society International (OARSI) 2004 responder criteria were used to assess efficacy. The consumption of rescue medication was a secondary outcome. Adverse events were recorded for safety purposes.

resultsAt the 40-month visit significantly more patients responded to HA compared with placebo (OARSI 2004, p=0.004). The number of responders to HA increased through the study, whereas those to placebo did not change. Significant differences were also found in favour of HA for each individual component of the OARSI 2004. No safety problems were recorded.

conclusionsThe results of AMELIA offer pioneer evidence that repeated cycles of intra-articular injections of HA not only improve knee osteoarthritis symptoms during the in-between cycle period but also exert a marked carry-over effect for at least 1 year after the last cycle. In this respect, it is not possible to establish if this carry-over effect reflects true osteoarthritis remission or just a modification of the disease's natural course. ClinicalTrials.gov number, NCT00669032.

Indexed as

AgedDisease ProgressionDrug Administration ScheduleFemaleHumansHyaluronic AcidInjections, Intra-ArticularMaleMiddle AgedOsteoarthritis, KneePain MeasurementSingle-Blind MethodTreatment OutcomeViscosupplementationViscosupplementsHyaluronic AcidViscosupplements

Identifiers

PMID21852252
PMCPMC3184238
OpenAlexW2150215466

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.