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Published in: BMC Musculoskeletal Disorders 1/2009

Open Access 01-12-2009 | Research article

A multi-center, randomized, clinical study to compare the effect and safety of autologous cultured osteoblast(Ossron™) injection to treat fractures

Authors: Seok-Jung Kim, Yong-Woon Shin, Kyu-Hyun Yang, Sang-Bum Kim, Moon-Jib Yoo, Suk-Ku Han, Soo-Ah Im, Yoo-Dong Won, Yerl-Bo Sung, Taek-Soo Jeon, Cheong-Ho Chang, Jae-Deog Jang, Sae-Bom Lee, Hyun-Cho Kim, Soo-Young Lee

Published in: BMC Musculoskeletal Disorders | Issue 1/2009

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Abstract

Background

We performed a multicenter, open, randomized, clinical study of autologous cultured osteoblast injection for long-bone fracture, to evaluate the fracture healing acceleration effect and the safety of autologous cultured osteoblasts.

Methods

Sixty-four patients with long-bone fractures were randomly divided into two groups, i.e. those who received autologous cultured osteoblast injection and those who received no treatment. The sum of the difference in the callus formation scores after four and eight weeks, was used as the first efficacy variable.

Results

The autologous cultured osteoblast injection group showed fracture healing acceleration of statistical significance, and there were no specific patient complications when using this treatment.

Conclusion

Autologous cultured osteoblast injection should therefore be considered as a successful treatment option for treating long-bone fracture.

Trial registration

Current Controlled Trials ISRCTN10637905
Appendix
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Metadata
Title
A multi-center, randomized, clinical study to compare the effect and safety of autologous cultured osteoblast(Ossron™) injection to treat fractures
Authors
Seok-Jung Kim
Yong-Woon Shin
Kyu-Hyun Yang
Sang-Bum Kim
Moon-Jib Yoo
Suk-Ku Han
Soo-Ah Im
Yoo-Dong Won
Yerl-Bo Sung
Taek-Soo Jeon
Cheong-Ho Chang
Jae-Deog Jang
Sae-Bom Lee
Hyun-Cho Kim
Soo-Young Lee
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2009
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-10-20

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