Abstract
BACKGROUND: External fixation is an effective treatment for high-energy tibial shaft fractures (HETSFs), often with severe soft tissue damage. The purpose of this study was to provide preliminary insights into potential differences in clinical outcomes between the Carefix Hexaxial Spatial Frame (CHSF) and the Ilizarov Circular External Fixator (ICEF) in the definitive treatment of HETSFs. METHODS: We retrospectively analyzed 46 HETSFs patients, treated with CHSF (n = 26) or ICEF (n = 20), in our department from January 2019 to July 2022. The patient characteristics, operation time, radiological union time, external fixation time, final radiological outcomes, complications, and clinical outcomes were collected and analyzed. Complications that occurred during the treatment were classified according to Paley, which categorizes complications into three groups: problems, obstacles, and sequelae. The final clinical assessment was conducted using the criteria established by the Association for the Study and Application of the Method of Ilizarov (ASAMI) during the patients’ last follow-up visit. The mean follow-up time was 17.2 ± 2.8 months (range 12–24 months). RESULTS: The CHSF had a significantly shorter operation time (85.9 ± 11.5 min) than the ICEF (95.8 ± 4.2 min) (P < 0.001). Both groups achieved full bone clinical union. Radiological union time was similar: CHSF (24.5 ± 3.2 weeks) vs. ICEF (25.8 ± 3.5 weeks) (P > 0.05). External fixation duration (equivalent to clinical union time) was similar: CHSF (26.0 ± 3.8 weeks) vs. ICEF (26.5 ± 4.1 weeks) (P > 0.05). Translation and angulation in lateral view for the CHSF were all less than those for the ICEF (P < 0.001). Complication rates were comparable: CHSF 57.7%, ICEF 55.0%. No significant difference in ASAMI scores and complication rates was noted between groups at final follow-up (P > 0.05). CLINICAL TRIAL NUMBER: Not applicable. CONCLUSION: In terms of final clinical outcomes, our findings suggest that both CHSF and ICEF may achieve comparable therapeutic effects for HETSFs, with no significant difference in complication rates. CHSF appeared to demonstrate shorter operation times and improved radiological alignment compared to ICEF.