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Clinical outcomes of tibiotalocalcaneal arthrodesis using a retrograde femoral nail versus a dedicated hindfoot fusion nail in charcot neuroarthropathy: A prospective observational study in a resource-limited setting.
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Hamoud Moaaz Ali, Swealem Ahmed, Abdelhady Khaled Saad, Hatata Mohamed
Аннотация
BACKGROUND: Dedicated hindfoot fusion nail (HFN) systems for Charcot tibiotalocalcaneal (TTC) arthrodesis may be unavailable or unaffordable in resource-limited settings. A retrograde femoral nail (RFN) can serve as a pragmatic contingency implant when a dedicated HFN is unavailable. This study compared functional, radiographic, union, complication, and implant acquisition-cost outcomes between RFN and HFN.
METHODS: A prospective, non-randomized, two-arm observational study was conducted in 60 patients undergoing TTC arthrodesis for Charcot neuroarthropathy, consecutively allocated to RFN (n = 30) or HFN (n = 30) according to implant availability. Patients were followed for 24 months. Functional outcomes (AOFAS, VAS, ODI, FAAM), radiographic union, complications, and implant acquisition costs were assessed. Multivariable linear regression adjusted the 24-month AOFAS comparison for prespecified baseline covariates.
RESULTS: At 24 months, no statistically significant between-group differences were detected in functional outcomes (AOFAS: 77.76 vs. 78.24, p = 0.800). RFN had a lower implant acquisition cost (USD 2126 vs. USD 3374; mean difference -USD 1248, p < 0.001), although this represents implant cost only and not total treatment cost. Radiographic union occurred in 27/30 RFN patients (90%) and 30/30 HFN patients (100%) (absolute risk difference -10%, 95% CI -26% to +3%; p = 0.237). Among patients who achieved radiographic union, the observed time to union was 12.8 versus 14.4 weeks; however, this difference is of uncertain clinical relevance and excludes the three RFN nonunions.
CONCLUSION: In this prospective observational cohort, RFN was associated with broadly similar measured functional outcomes and complication rates to HFN when the dedicated implant was unavailable. The study does not establish equivalence or biomechanical interchangeability. The three RFN nonunions are clinically more important than the small difference in time to radiographic union. RFN may therefore be considered a pragmatic contingency option in resource-limited settings, while purpose-designed HFN remains the preferred dedicated implant when available.
METHODS: A prospective, non-randomized, two-arm observational study was conducted in 60 patients undergoing TTC arthrodesis for Charcot neuroarthropathy, consecutively allocated to RFN (n = 30) or HFN (n = 30) according to implant availability. Patients were followed for 24 months. Functional outcomes (AOFAS, VAS, ODI, FAAM), radiographic union, complications, and implant acquisition costs were assessed. Multivariable linear regression adjusted the 24-month AOFAS comparison for prespecified baseline covariates.
RESULTS: At 24 months, no statistically significant between-group differences were detected in functional outcomes (AOFAS: 77.76 vs. 78.24, p = 0.800). RFN had a lower implant acquisition cost (USD 2126 vs. USD 3374; mean difference -USD 1248, p < 0.001), although this represents implant cost only and not total treatment cost. Radiographic union occurred in 27/30 RFN patients (90%) and 30/30 HFN patients (100%) (absolute risk difference -10%, 95% CI -26% to +3%; p = 0.237). Among patients who achieved radiographic union, the observed time to union was 12.8 versus 14.4 weeks; however, this difference is of uncertain clinical relevance and excludes the three RFN nonunions.
CONCLUSION: In this prospective observational cohort, RFN was associated with broadly similar measured functional outcomes and complication rates to HFN when the dedicated implant was unavailable. The study does not establish equivalence or biomechanical interchangeability. The three RFN nonunions are clinically more important than the small difference in time to radiographic union. RFN may therefore be considered a pragmatic contingency option in resource-limited settings, while purpose-designed HFN remains the preferred dedicated implant when available.