Delays to Surgery and Coronal Malalignment Are Associated with Reoperation after Open Tibia Fractures in Tanzania.

BACKGROUND: Treatment of diaphyseal open tibia fractures often results in reoperation and impaired quality of life. Few studies, particularly in resource-limited settings, have described factors associated with outcomes after these fractures. QUESTIONS/PURPOSES: (1) Which patient demographic, perioperative, and treatment characteristics are associated with an increased risk of reoperation after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? (2) Which patient demographic, perioperative, and treatment characteristics are associated with worse 1-year quality of life after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? METHODS: A prospective study was completed in parallel to a similarly conducted RCT at a tertiary referral center in Tanzania that enrolled adult patients with diaphyseal open tibia fractures from December 2015 to March 2017. Patients were treated with either a statically locked intramedullary nail or external fixator and examined at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The primary outcome, reoperation, was any deep infection or nonunion treated with a secondary intervention. The secondary outcome was the 1-year EuroQol-5D (EQ-5D) index score. There were 394 patients screened and ultimately, 267 patients enrolled in the study (240 from the primary RCT and 27 followed for the purposes of this study). Of these, 90% (240 of 267) completed 1-year follow-up and were included in the final analysis. This group comprised 110 patients who underwent IMN and 130 who had external fixation; follow-up was similar between study groups. Patients were an average of 33 years old and were primarily males who sustained road traffic injuries resulting in AO/Orthopaedic Trauma Association (OTA) classification type A or B fractures. There were 51 reoperations. For the purposes of analysis, all patients were pooled to identify all other factors, in addition to treatment type, associated with increased risk of reoperation and 1-year quality of life. An exploratory bivariable analysis identifying various factors associated with reoperation risk and EQ-5D was subsequently included in a multivariate modeling procedure to control for confounding of effect on our primary outcome. Multivariable modeling was performed using standard hierarchical modeling simplification procedures with log-likelihood ratios. Alpha levels were set to 0.05. RESULTS: After controlling for potentially confounding variables such as gender, smoking status, mechanism of injury, and treatment type, the following factors were independently associated with reoperation: Time from hospital presentation to surgery more than 24 hours (odds ratio 7.7 [95% confidence interval 2.1 to 27.8; p = 0.002), AO/OTA fracture classification Type 42C fracture (OR 4.2 [95% CI 1.2 to 14.0]; p = 0.02), OTA-Open Fracture Classification muscle loss (OR 7.5 [95% CI 1.3 to 42.2]; p = 0.02), and varus coronal angle on an immediate postoperative AP radiograph (OR 4.8 [95% CI 1.2 to 14.0]; p = 0.002). After again controlling for confounding variables such as gender, smoking status, mechanism of injury, and treatment type factors independently associated with worse 1-year EQ-5D scores included: Wound length ≥ 10 cm (ß = [change in EQ-5D score] -0.081 [95% CI -0.139 to -0.023]; p = 0.006), OTA-Open Fracture Classification muscle loss (ß = -0.133 [95% CI -0.215 to -0.051]; p = 0.002), and OTA-Open Fracture Classification bone loss (ß = -0.111 [95% CI -0.208 to -0.013]; p = 0.03). We observed a modest, but independent association between reoperation and worse 1-year EQ-5D scores (ß = -0.113 [95% CI -0.150 to -0.077]; p < 0.001). CONCLUSIONS: We found two potentially modifiable factors associated with the risk of reoperation: reducing time to surgical treatment and avoiding varus coronal angulation during definitive stabilization. Hospitals may be able to minimize time to surgery, and thus, reoperation, by increasing the number of available operative personnel and space and emphasizing the importance of open tibia fractures as an injury requiring emergent orthopaedic management. Given the lack of fluoroscopy in the study setting and similar settings, surgeons should emphasize appropriate fracture alignment, even into slight valgus, to avoid varus angulation and subsequent reoperation risk. LEVEL OF EVIDENCE: Level II, therapeutic study.

Surgical Implant Generation Network (SIGN) Fin nail versus SIGN standard intramedullary nail for distal diaphyseal femur fractures treated via retrograde approach.

INTRODUCTION: Surgical fixation of distal diaphyseal femur fractures remains a major challenge in developing countries given limited availability of fluoroscopy. The Surgical Implant Generation Network (SIGN) Standard Intramedullary Nail and SIGN Fin Nail are two modalities developed to address this challenge; the Fin Nail additionally avoids needing to place proximal interlocking screws. While efficacy of the Standard Nail has been established, outcomes following fixation with the Fin Nail are unknown. In this study, we compare outcomes of distal diaphyseal femur fractures treated with each implant. METHODS: A prospective cohort study was conducted from 2012 to 2013 at a single tertiary-referral center in Tanzania. Skeletally mature patients with distal diaphyseal femur fractures treated with either retrograde SIGN Standard Nail or Fin Nail were included. Patients followed-up at 6, 12, 26, and 52 weeks post-operatively. The primary outcome was all-cause reoperation. Secondary outcomes included infection, non-union, malalignment, quality of life (EQ-5D score), pain (VAS score), radiographic healing (RUST score), and function (pain with weight bearing, knee range of motion, and Squat and Smile score). RESULTS: 74 (85%) of 85 enrolled patients completed the minimum 1-year follow-up. There was no difference in rate of reoperation (p = 1.00), infection (p = 1.00), limb length discrepancy (p = 0.47), non-union (p = 1.00), or coronal or sagittal malalignment (p = 1.00, p = 0.55 respectively) at 1 year. There was furthermore no difference in mean EQ-5D (p = 0.82), VAS pain score (p = 0.43), RUST score (p = 0.44), maximum knee flexion (p = 0.52) and extension (p = 1.00), or Squat and Smile function (p = 1.00) between cohorts at 1 year. DISCUSSION: Outcomes associated with the SIGN Fin Nail are comparable to those associated with the SIGN Standard Intramedullary Nail at 1 year. The SIGN Fin Nail may be useful as an alternative to Standard locked IM nails for fixation of distal diaphyseal femur fractures.