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International Orthopaedics
Published in: International Orthopaedics 2/2021

01-02-2021 | Knee Osteoarthritis | Original Paper

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

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

Published in: International Orthopaedics | Issue 2/2021

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Abstract

Purpose

To 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).

Methods

During 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.

Results

KOOS 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.

Conclusion

PoC 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.
Appendix
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Metadata
Title
Intra-articular gold induced cytokine (GOLDIC®) injection therapy in patients with osteoarthritis of knee joint: a clinical study
Authors
Ulrich Schneider
Ashok Kumar
William Murrell
Agnes Ezekwesili
Nagib A. Yurdi
Nicola Maffulli
Publication date
01-02-2021
Publisher
Springer Berlin Heidelberg
Published in
International Orthopaedics / Issue 2/2021
Print ISSN: 0341-2695
Electronic ISSN: 1432-5195
DOI
https://doi.org/10.1007/s00264-020-04870-w

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