Evidence map›Paper›PMID 34162365›Full record

Trial reportBMC musculoskeletal disorders2021

Safety and efficacy of single CHAP Hyaluronan injection versus three injections of linear Hyaluronan in pain relief for knee osteoarthritis: a prospective, 52-week follow-up, randomized, evaluator-blinded study.

Teng-Le Huang, Chun-Hao Tsai

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

Trial report in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03643588 (Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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.

NCT03643588 nacompletednot on this map

Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain

TypeinterventionalSponsorSciVision Biotech Inc.Ran2015 to 2017Enrolled140ConditionsOsteoarthritis, KneeArmsHYAJOINT Plus, Hyalgan
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Cross-Linked Versus Linear Hyaluronic Acid for Cartilage Repair in Rat Post-Traumatic Osteoarthritis.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2026
    Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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

2 authors at 1 institution in 1 country.

Teng-Le HuangJoint Replacement Center, Jen-Ai hospital, No.483, Dongrong Rd., Dali Dist, Taichung, Taiwan.
Chun-Hao TsaiDepartment of Orthopedics, China Medical University Hospital, No.91 Hsueh-Shih Road, Taichung, 404, Taiwan. ritsai8615@gmail.com.ORCID http://orcid.org/0000-0002-4428-3132
China Medical University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients. We conducted the study comparing the efficacy and safety of single injection of Crosslinked Hyaluronic Acid Platform Hyaluronan (CHAP-HA) with 3-injection of linear hyaluronan in knee OA patients.

methodsThis was a randomized two-arms, evaluator-blinded, controlled, single-center study. Participants with knee OA received single CHAP-HA or three-injection of linear-HA. The 140 patients aged 35-85 years with radiographically confirmed knee OA were enrolled. At week 4, 12, 26, 39, and 52, visual analog scale (VAS) pain score, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, timed up and go (TUG) and subject's adverse events (AE) of these 2 groups were recorded. Primary outcome of the differences of VAS pain score at week 26 between groups was analyzed with analysis of covariance (ANCOVA). At week 52, those who met the inclusion criteria could receive a CHAP-HA injection and being followed-up for the adverse events for 4 weeks.

resultsThe trial was conducted from September 2015 to April 2017. A total 140 subjects were available for analysis (71 in the CHAP-HA group and 69 in the linear-HA group). At 26th week, there were significant more improvements in VAS pain scores in CHAP-HA compared with linear-HA. Both CHAP-HA and linear-HA showed significant improvements in the VAS pain score at week 26 compared with the baseline, and the occurrence of adverse events during the study period showed no between-group difference. In subjects with KL = 2, both groups showed significant improvements in VAS pain scores within 26 weeks. In patients with KL = 3, only CHAP-HA group showed significant improvement in VAS pain from 4 to 39 weeks. No unexpected or severe AEs were reported.

conclusionsA single injection of CHAP-HA may be safe and more effective for 26 weeks in patients with knee OA by comparing to linear-HA; moreover, the pain relief effect of CHAP-HA may remain until 52 weeks. For patients with more severe OA, CHAP-HA was demonstrated to be more preferable to relieve OA pain. Furthermore, repeat treatment of CHAP-HA or using CHAP-HA after a three-injection HA was proved to be safe.

trial registrationClinicalTrials.gov : NCT03643588 . Date: August 23, 2018 (retrospectively registered). LEVEL OF EVIDENCE: Therapeutic Level I.

Indexed as

Hyaluronic AcidOsteoarthritis, KneeFollow-Up StudiesHumansInjections, Intra-ArticularOntarioPainProspective StudiesTreatment OutcomeHyaluronic AcidHyaluronic acidKnee osteoarthritisViscosupplementationWOMAC

Identifiers

PMID34162365
PMCPMC8223367
OpenAlexW3177015589

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.