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Open Access 19-04-2023 | External Fixator | Original Paper

Clinical trial of a low-cost external fixator for global surgery use

Authors: Giovanni Milandri, P. C. I. Wijesinghe, Dilshan Munidasa, Cinthuja Pathmanathan, Mehdi Saeidi, Anthony M. J. Bull, Pujitha Silva

Published in: International Orthopaedics | Issue 7/2023

Abstract

Purpose

A low-cost modular external fixator for the lower limb has been developed for global surgery use. The purpose of this study is to assess outcome measures in the first clinical use of the device.

Methods

A prospective cohort study was conducted with patients recruited in two trauma hospitals. Initial clinical procedure data were collected, and patients were followed up every two weeks until 12 weeks or definitive fixation. Follow-up assessed infection, stability, and radiographic outcomes. In addition, patient-reported outcomes and surgeons’ feedback on device usability were collected by questionnaires.

Results

The external fixator was used on 17 patients. Ten were mono-lateral, five were joint spanning, and two were delta configuration. One patient had a pin site infection at 12-week follow-up. All were stable when tested mechanically and using radiographic assessment, and 53% were converted to definitive fixation.

Conclusion

The low-cost external fixator developed is appropriate for use in global surgery trauma centres with good clinical outcomes.

Prospective trial registration number and date

SLCTR/2021/025 (06 Sep 2021).

https://www.imperial.ac.uk/external-fixator/

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Title: Clinical trial of a low-cost external fixator for global surgery use
Authors: Giovanni Milandri
P. C. I. Wijesinghe
Dilshan Munidasa
Cinthuja Pathmanathan
Mehdi Saeidi
Anthony M. J. Bull
Pujitha Silva
Publication date: 19-04-2023
Publisher: Springer Berlin Heidelberg
Keyword: External Fixator
Published in: International Orthopaedics / Issue 7/2023
Print ISSN: 0341-2695
Electronic ISSN: 1432-5195
DOI: https://doi.org/10.1007/s00264-023-05807-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Clinical trial of a low-cost external fixator for global surgery use

Abstract

Purpose

Methods

Results

Conclusion

Prospective trial registration number and date

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Prospective trial registration number and date

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