Randomized controlled trial comparing stabilization of fresh close femoral shaft fractures in children with titanium elastic nail system versus stainless steel elastic nail system.

In vitro mechanical studies have demonstrated equal or superior fixation of pediatric femoral fractures with use of titanium elastic nails (TENS) as compared with stainless steel elastic nails (SSEN). SSEN are less expensive as compared to TENS. However, there are only two studies in the English literature which have compared the results of TENS and SSEN in paediatric femoral shaft fracture. The present study compares the clinical and radiological outcomes of femoral shaft fracture in patients 6-12 years of age, operatively stabilised either by TENS or SSEN. 35 children (6-12 years) with closed, post traumatic femoral shaft fractures were randomized into two treatment groups. Both groups underwent closed reduction internal fixation (CRIF) by either of the implants (TENS OR SSENS) as per randomization protocol and followed up for six months. Comparison of clinical and radiological outcomes in both the groups was done in terms of time to union of fracture and radiological angulations in coronal and sagittal plane. There was no significant difference in both groups with respect to fracture site tenderness and presence of bridging callus at fracture site at 3 weeks, 6 weeks and 6 months follow up (p-value = 1.000). There was no significant difference in radiological angulation rate in both groups in the sagittal (p-value = 0.661) as well as in the coronal plane (p-value = 0.219) at six month follow up. Both groups showed a similar rate of complication, most common being prominent hardware. TENS and SSENS are equally effective treatment modalities for paediatric femoral shaft fracture with similar rate of complications. However, SSENS is less costly as compared to TENS and can be considered as an alternative in a resource constrained setup.