Evidence map›Paper›PMID 38698396›Full record

ArticleJournal of orthopaedic surgery and research2024

Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study.

Henning Bliddal, Jannie Beier, Andreas Hartkopp, Philip G Conaghan, Marius Henriksen

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of orthopaedic surgery and research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04179552 (Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT04179552 nacompletednot on this map

Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis

TypeinterventionalSponsorConturaRan2019 to 2024Enrolled49ConditionsOsteoarthritis, KneeArmsPAAG-OA
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Recent advances in injectable hydrogels for osteoarthritis treatments.Frontiers in bioengineering and biotechnology · 2025
    Review
  9. Review
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

5 authors.

Henning BliddalThe Parker Institute, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Ndr. Fasanvej 57, 2000, Copenhagen, Frederiksberg, Denmark. henning.bliddal@regionh.dk.
Jannie BeierRheumatolog i Odense, Odense, Denmark.
Andreas HartkoppA2 Rheumatology and Sports Medicine, Holte, Denmark.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK.
Marius HenriksenThe Parker Institute, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Ndr. Fasanvej 57, 2000, Copenhagen, Frederiksberg, Denmark.

Funding

OAK Foundation OCAY-18-774-OFIL
6 · The paper itself

Abstract

objectiveThere are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data.

methodsThis multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).

results49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.

conclusionThis open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.

trial registrationClinicaltrials.gov NCT04179552.

Indexed as

Acrylic ResinsOsteoarthritis, KneeAgedAged, 80 and overFemaleFollow-Up StudiesHumansHydrogelsInjections, Intra-ArticularMaleMiddle AgedTime FactorsTreatment OutcomeAcrylic ResinsHydrogelspolyacrylamide gelsIntra-articularKneeOsteoarthritisPainPolyacrylamideWOMAC

Identifiers

PMID38698396
PMCPMC11064315

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.