Elastic stable intramedullary nailing versus submuscular plating in pediatric diaphyseal femur fractures: a randomized controlled trial among children in South India

Abstract

Elastic stable intramedullary nailing (ESIN) is the current preferred method for treating diaphyseal femur fractures in children. Introduction of the submuscular locked plate (SMP) fixation construct has opened the debate on treatment options for pediatric diaphyseal femur fractures in the older children and adolescents. A randomized controlled trial (RCT) protocol was designed to compare ESIN and SMP for diaphyseal femur fractures in children. An open-labelled RCT comparing SMP with ESIN was conducted from January 2013 to June 2016, for children aged 6-15 years with closed, acute femoral diaphyseal fractures. Randomization was done through computergenerated randomization sequence and opaque-sealed envelopes. Rate of adverse surgical events including unplanned re-operations was assessed as the primary outcome and secondary analysis was done for time to union, degree of malunion, limb length discrepancy, functional outcome at 2 years, surgical duration and blood loss, radiation exposure, hospital stay, cost incurred and secondary implant removal procedure. Forty children were randomized with allocation concealment. There were three adverse events in the SMP arm and five in the ESIN arm. Fifteen children with SMP underwent routine implant removal compared to only three children with ESIN (P < 0.001). Both ESIN and SMP are equally safe, viable and effective options for treating pediatric diaphyseal femoral fractures. However, the additional cost of secondary surgery for implant removal in the SMP group proved to be a deterrent factor, which led to ESIN being the preferred option in our resource-limited setting. J

Elastic stable intramedullary nail fixation versus submuscular plate fixation of pediatric femur shaft fractures in school age patients: A PRISMA-compliant systematic review and meta-analysis

“…Three studies mentioned the outcome of radiation time. [8,15,19] There was significant difference in the ESIN and SMP group (MD = 8.84; 95% CI = −46.42 to 64.11, P = .0003) (Fig. 3C).…”

“…Data were extracted from 4 studies to evaluate the operation time. [15,17,19,20] The difference was statistically significant between ESIN and SMP groups (MD = −16.16; 95% CI = −22.83 to −9.48, P < .00001) (Fig. 3A).…”

“…The outcome measure of blood loss during the operation was available in 4 studies. [15,17,19,20] The meta-analysis showed a significant difference between the ESIN and SMP groups (MD = −53.62; 95% CI = −58.89 to −48.36, P < .00001) (Fig. 3B).…”

“…The remaining 8 articles involving 561 patients met the inclusion criteria and were included in this review. [8,12,[15][16][17][18][19][20] Figure 1 shows the results flow chart for the whole search process.…”

Length Unstable Femoral Shaft Fractures in Children: It's Time for a New Definition

“…Several comparative studies have shown shorter operative times and less blood loss with ESIN as compared with plating as well as secondary implant removal being more problematic with plates. 9,15,16 Add to this, the delayed complication of distal femoral valgus deformity that may develop in up to 30% of patients after femoral shaft plate fixation, and the hesitation to embrace this approach only increases. 17 Taking all of this into consideration, the current work by Nixon et al in addition to the 6 cited similar studies leave little question regarding the effectiveness of ESIN in most unstable fracture patterns.…”