School of Podiatric Medicine - Medical Student Research

Document Type

Poster

Publication Date

2024

Abstract

Statement of Purpose: External fixators in the United States are sold as single-use devices. Though their efficacy is well documented, they remain underutilized due to expense. The aim of this study is to determine if it is safe to reprocess and reuse external fixator components to lower the cost burden of surgeries using external fixation.

Introduction: External fixation is a critical but costly modality for upper and lower limb pathologies, such as trauma, deformity correction, and nonunion. Despite the clinical effectiveness of external fixation using delta, ilizarov, and hexapod frames, its application in the United States as a single-use device exacerbates its financial burden on healthcare systems and patients. A proposed cost-control measure is the reuse/reprocessing of external fixator materials by means of (1) pre-treatment with antiseptics, (2) assessment for structural stability, and (3) autoclave sterilization. Per Song, an estimated 25% cost savings are reported after reprocessing and reusing external fixator materials. Additionally, these reprocessed external fixators were not inferior to single-use external fixators in terms of adverse patient outcomes such as infection or mechanical failures leading to loss of fixation per Song and Chironga.

This review hopes to examine the current body of literature to investigate the viability of reused/reprocessed external fixation - thus expanding surgical options for providers managing patients with complex limb pathology.

We hypothesize that this review will find no statistically significant difference in clinical outcomes of reused vs. new external fixation.

Methodology & Procedures: Investigators reviewed current literature published in PubMed, Cochrane, Web of Science, and Google Scholar for candidate articles. Search terms “External Fixator Frame” and “Reuse” applied in these databases for retrieval and reproducibility purposes.

Search strategy :

Parameters were set for articles that would be included in the study and documented using a PRISMA flow chart. Candidate articles were screened by both reviewers using exclusion criteria: duplicate, paper not available in English, paper does not meet search term definitions, full text not available, published before 2004, not being original research, and full text not available. Papers were included if they passed screening by both reviewers.

Results: Systematic searching yielded nineteen total results. Only two pertinent papers were identified through exclusion criteria. A total of forty-six (46) Delta frames, seventeen (17) Hexapod frames, and eight (8) Ilizarov Frames were reprocessed. Pathologies indicated for external fixation were Non-Union, Deformity Correction, Pilon Fracture, Tibial Plateau Fracture, Complex Open Tibia & Fibula Fracture, and Distal Radial Fracture. Common complications were pin tract infections, loosening of the frame, and loss of fixation. The total shared pathologies between analyzed papers were thirty-one (31) pilon fractures and twenty-four (24) tibial plateau fractures. Both papers found statistically significant evidence that reprocessed external fixator frames had no loss of mechanical stability compared to single-use counterparts. The Sung paper showed no significant difference in infection outcome between reprocessed and single-use external fixator materials such as frames and pins. Reprocessed Ilizarov frames reported cost savings of sixty-three percent (63%) and reprocessed Hexapod frames reported savings of fifty-two percent (52%). Delta frame cost savings were noted at twenty-five percent (25%).

Analysis & Discussion (Conclusion): This review found that Reprocessed External Fixation was not inferior to Single-Use External Fixation regarding adverse outcomes. Adverse outcomes measured were infection and mechanical failure leading to loss of fixation or frame structural integrity.

Reprocessed Ilizarov and Hexapod frames reduce material costs by 50%, and Delta frames reduce costs by 25%. Reusing external fixator frames and pins is a viable means of reducing healthcare costs, as proven by the Sung study, which had a total cost savings of $65, 452 by reprocessing forty-six (46) frames and pins.

This review was limited by Chironga's failure to differentiate pathology types when recording external fixation outcomes. Therefore, pilon vs. tibial plateau fracture outcomes could not be differentiated, and no conclusions could be drawn on specific pathologies. External Fixator frames are normally reused for 2-3 procedures on average but not by any specific protocol, raising the question of how often these frames may be safely reprocessed.

This line of inquiry would benefit from more research on specific pathological outcomes, on reusing fixator pins specifically, and on long-term post-op outcomes. Other promising means of reducing external fixation costs are 3D-printed frame components and standardized components across manufacturers.

Our search found many papers on external fixation frame integrity that did not consider patient outcomes. One excluded paper analyzed reprocessed frames without comparison to single-use frames; this data had a significantly higher infection rate than baseline (52% vs. 10%), leading to patient safety questions. Any further conclusions on patient outcomes would require higher-powered studies with randomization and controls, or meta-analyses of quality case series.

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