SLR - August 2021 - Keegan A. Duelfer

A Prospective, Randomized, Controlled, Two-Centre, International Trial Comparing the Fibular Nail with Open Reduction and Internal Fixation for Unstable Ankle Fractures in Younger Patients

Reference: White T, Bugler K, Olsen L, Holck Lundholm L, Holck K, Lindegaard Madsen B, Duckworth A. A Prospective, Randomized, Controlled, Two-Centre, International Trial Comparing the Fibular Nail with Open Reduction and Internal Fixation for Unstable Ankle Fractures in Younger Patients. Journal of Orthopaedic Trauma. 2021 April.

Level of Evidence: Therapeutic Level 1

Scientific Literature Review

Reviewed By: Keegan A. Duelfer, DPM
Residency Program: Regions Hospital / Health Partners Institute - St. Paul, MN

Podiatric Relevance: This article reviews another fixation option for unstable ankle fractures in patients under the age of 65 with the highest level of evidence. Nail fixation in fibula fractures have been well described in the literature for patients with lower bone density, such as elderly patients or those with osteoporosis. This is the first paper exploring this fixation option in younger patients. The aim of this trial was to determine whether there was a superior, clinically relevant difference between fibular nail and standard plate fixation. 

Methods: This study is a level one randomized controlled clinical trial comprised of 125 adult patients between 18-64 years of age who had suffered unstable ankle fractures. Patients were randomized to fixation with fibular nail or standard ORIF with stainless steel implants. Clinical, functional, and radiographic assessments were performed at six weeks, three months, six months, one year and two years. The primary outcome measured in this study was the Olerud and Molander Score (OMS), a validated and reliable ankle fracture scoring scale, at one-year. Secondary outcomes measured in this study were the rates of complications and re-interventions. 

Results: Regarding the primary outcome measure, the mean OMS was 78.4 in the nail group and 80.2 in the plate group which was not a statistically significant difference. No difference was seen in the overall rate of complications and re-interventions between the two groups (28.6 percent in the nail group vs. 29 percent in the plate group). 

Conclusions: The authors conclude that there was no difference in the patient-reported outcomes between fibular nail and plate fixation at one-year postoperative in younger patients with ankle fractures. They also state that the fibular nail is an effective and safe option for the stabilization of ankle fractures in younger patients, although the benefits associated with reduced wound complications are not as apparent as they are in the elderly patient population. The reviewer of this paper agrees that there are no apparent disadvantages to nail fixation versus standard plate and screws. At this point in time, it is difficult to assign an advantage to nail fixation from a patient outcome perspective or complication rate perspective. The authors admit that a significant minority of the patients in this study were smokers or suffering from one or more significant comorbidities, however they do not mention if this had an effect on the primary or secondary outcomes in this study. Additional information may have been derived from separating smokers and patients suffering from one or more significant comorbidities from the rest of the general patient population to more fully assess the effects of the two fixation options. The reviewer concludes that cost of the fixation options and further research into the effect of the fixation on smokers and those with comorbidities would need to be factored in before choosing to utilize nail fixation in unstable ankle fractures in patients younger than 65 years old. 

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