SLR - October 2023 - Lanoue
Title: Outcomes of Intramedullary Nailing and External Fixation of Open Tibial Fractures: Three to Five-Year Follow-up of a Randomized Clinical TrialReference: Cortez A, Urva M, Haonga B, Donnelley CA, von Kaeppler EP, Roberts HJ, Shearer DW, Morshed S. Outcomes of Intramedullary Nailing and External Fixation of Open Tibial Fractures: Three to Five-Year Follow-up of a Randomized Clinical Trial. J Bone Joint Surg Am. 2022 Nov 2;104(21):1877-1885.
Level of Evidence: Level IV – Therapeutic trial
Scientific Literature Review
Reviewed By: Mary Lanoue DPM, PGY-2
Residency Program: Highlands / Presbyterian St. Luke’s Medical Center
Podiatric Relevance: Open tibial fractures are one of the most common reasons for orthopedic hospitalization with a high risk of major complications. Currently there is a lack of consensus for stabilization techniques using an intramedullary nail (IMN) or external fixation (EF) for open tibial injuries. This current study observes complications in an extended follow-up for open tibial fractures managed with either IMN or EF.
Methods: A randomized control trial in Tanzania comparing IMN and EF for open tibial shaft fractures evaluated 221 patients (111 IMN, 110 EF) with at least 1 year follow-up from December 2015-March 2017. This study reported management in low- and middle-income countries with extended follow-up of the original participants from January 2020-February 2021 evaluated primary events and secondary outcomes. Primary events included death, reoperation, deep infection, nonunion, and malalignment. Secondary outcomes evaluated quality of life surveys (EQ-5D-3L, EQ-VAS), functional outcomes (FIX-IT score), radiographic measurements, and healing (mRUST scores).
Results: Of the original 240 patients evaluated, 126 patients (52.5%) were included in the extended follow up. The extended follow up included 67 patients managed with IMN and 59 patients managed with EF,with an average time from injury to follow-up of 4.0 years. Primary events were reported in 32/126 patients, 16 in the IMN group and 16 in the EF group. Of the primary events, reoperation for deep infection occurred in 15.1% of patients (11 IMN, 8 EF), reoperation for nonunion in 4.8% of patients (2 IMN, 4 EF), reoperation for malalignment in 1.6% of patients (1 IMN, 1 EF), and death in 4.0% of patients (2 IMN, 3 EF). New events at the end of the extended follow up was reported in 18.8% of patients including death (1 IMN, 1 EF), deep infection (1 IMN, 2 EF), and nonunion (1 IMN). At 18 month follow up, 87% of the fracture related infection (FRI) diagnoses were made. Functional outcome measures returned to baseline in both treatment groups at an average 4 year follow up. There were no differences in FIX-IT score, radiographic alignment, and mRUST scores between treatment groups. At final follow up, 25% of patients reported unresolved complications despite several reoperations including isolated infection (n=4), aseptic nonunion (n=2), and infected nonunion (n=2). Patients with infected nonunion had significantly lower EQ-5D-3L, EQ-VAS, FIX-IT, and mRUST scores.
Conclusions: The present study with extended follow up presented the concern for deep infection in the setting of fracture related infections. This data is relevant for surgical management and infection prevention in resource-limited facilities citing no differences between fixation in any primary or secondary outcome measures. At a mean of 4 years after injury, fracture related infection and nonunion become chronic conditions in nearly 25% of patients who experienced complications, regardless of IMN or EF intervention.