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

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).