gms | German Medical Science

54. Jahrestagung der Norddeutschen Orthopädenvereinigung e. V.

Norddeutsche Orthopädenvereinigung

16.06. bis 18.06.2005, Hamburg

Safety and efficacy of orthokine conditioned autologous serum (ACS) injections in knee osteoarthritis: a controlled, prospective, randomized, double blinded clinical study

Meeting Abstract

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  • corresponding author A. Baltzer - Gemeinschaftspraxis Königsallee, Düsseldorf
  • C. Moser - Düsseldorf
  • R. Krauspe - Düsseldorf

Norddeutsche Orthopädenvereinigung. 54. Jahrestagung der Norddeutschen Orthopädenvereinigung e.V.. Hamburg, 16.-18.06.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc05novP31

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/nov2005/05nov082.shtml

Veröffentlicht: 13. Juni 2005

© 2005 Baltzer et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Introduction

Intraarticular Hyaluronic Acid (HA) injections are a well accepted modality in therapy of Knee Osteoarthritis (OA). In this 3-armed study we compare effectiveness and safety of injected Orthokine-conditioned autologous serum (ACS) vs HA and Placebo (physiologic saline).

Method

The study protocol was approved by the ethics committee at Düsseldorf University. Enroled were more than 420 patients with uni- or bilateral X-ray confirmed OA grade 2-3 (Kellgren). Three (HA) or 6 (ACS & Placebo) injections were performed 1x or 2x per week. Objective and subjective outcome assessments were performed 9 times per patient. Follow up exams were taken at 3 and 6 months. Permitted additional treatment were walking stick and orthopaedic shoe inlays.

Results

We present for the first time data of a controlled, prospective, randomized double blinded clinical study designed to determine safety and efficacy of Orthokine ACS injections in Knee OA patients after 3 and after 6 months in direct comparison to HA and Placebo. Data collection includes WOMAC, SF8 and VAS. The statistical analysis is performed independently by the "Koordinierungsstelle für klinische Studien", University Düsseldorf.

Discussion

ACS, Placebo and HA injection therapies will be compared and data on safety, side effects and efficacy will be presented.