gms | German Medical Science

54. Jahrestagung der Norddeutschen Orthopädenvereinigung e. V.

Norddeutsche Orthopädenvereinigung

16.06. bis 18.06.2005, Hamburg

Article

Send article

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

Meeting Abstract

Search Medline for

  • 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

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/nov2005/05nov082.shtml

Published: June 13, 2005

© 2005 Baltzer et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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.