Evidence map›Paper›PMID 33404700›Full record

Trial reportInternational orthopaedics2021

Intra-articular gold induced cytokine (GOLDIC®) injection therapy in patients with osteoarthritis of knee joint: a clinical study.

Ulrich Schneider, Ashok Kumar, William Murrell, Agnes Ezekwesili, Nagib A Yurdi, Nicola Maffulli

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International orthopaedics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.1field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
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  11. Rehabilitation and Return to Sport of Female Athletes.Arthroscopy, sports medicine, and rehabilitation · 2022
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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

6 authors at 5 institutions in 4 countries.

Ulrich SchneideriRegMed, Tegernsee, Germany.ORCID 0000-0002-2252-5188
Ashok KumarMy Doc Specialist Medical Centre DMCC, Fortune Executive Tower, JLT, Dubai, United Arab Emirates.ORCID 0000-0002-6456-3342
William MurrellAbu Dhabi Knee and Sports Medicine, Healthpoint Hospital, Zayed Sports City, Abu Dhabi, United Arab Emirates. doctormurrell@gmail.com.ORCID 0000-0001-8835-1806
Agnes EzekwesiliDepartment of Nutrition, University of North Carolina, Chapel Hill, NC, USA.ORCID 0000-0003-2082-1087
Nagib A YurdiAbu Dhabi Knee and Sports Medicine, Healthpoint Hospital, Zayed Sports City, Abu Dhabi, United Arab Emirates.ORCID 0000-0002-4233-6069
Nicola MaffulliDepartment of Musculoskeletal Disorders, University of Salerno School of Medicine and Dentistry, Salerno, Italy.ORCID 0000-0002-5327-3702
Dubai Medical College · AEHealthpoint · AEUniversity of North Carolina at Chapel Hill · USUniversity of Salerno · ITWilliam Beaumont Army Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of a novel technique of preconditioning autologous blood with gold particles (GOLDIC®) and injection in patients with moderate to severe knee osteoarthritis (KOA).

methodsDuring this phase 2a, proof-of-concept (PoC) open label study, 83 consecutive patients that 64 patients met inclusion criteria (mean age: 64.8 years; 89 knees) with radiographically proven KOA, received four ultrasound guided intra-articular knee injections of GOLDIC® at three to six day intervals. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) were evaluated at baseline, four weeks, three, six months, one, two and four years (T1-T6). The incidence of treatment related severe adverse events (SAEs) recorded. Intra-articular gelsolin level in patients with effusion was determined.

resultsKOOS and WOMAC scores improved for the full duration of the study (P < 0.05), minimal clinically important difference (MCID) was observed at all time points in all KOOS subscores, with no reported SAEs. Intra-articular gelsolin level increased after treatment with reduction of effusion. No statistically significant evidence of an association between patient demographics and outcome were identified. Nine patients failed treatment, with 32 months mean time to failure and underwent total knee arthroplasty.

conclusionPoC study of GOLDIC® as a novel device for conservative management of moderate to severe KOA was confirmed. GOLDIC® produces rapid and sustained improvements in all indices after treatment, with no SAEs.

trial registration§ 13 Abs.2b AMG Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)-Date 3/20/2010 retrospectively registered.

Indexed as

Osteoarthritis, KneeCytokinesGoldHumansInjections, Intra-ArticularKnee JointMiddle AgedTreatment OutcomeCytokinesGoldBone marrow aspirate concentrateGoldicKnee generalPain managementPlatelet-rich plasmaStem cell therapy

Identifiers

PMID33404700
OpenAlexW3118629316

What OpenQuestion holds

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Registered trials

None linked

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.