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Randomized Controlled Trial
. 2020 Oct;34(10):524-532.
doi: 10.1097/BOT.0000000000001773.

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Gerard P Slobogean  1 , Sheila Sprague  2   3 , Sofia Bzovsky  2 , Taryn Scott  2 , Lehana Thabane  3 , Diane Heels-Ansdell  3 , Robert V O'Toole  1 , Andrea Howe  1 , Greg E Gaski  4 , Lauren C Hill  4 , Krista M Brown  4 , Darius Viskontas  5 , Mauri Zomar  6 , Gregory J Della Rocca  7 , Nathan N O'Hara  1 , Mohit Bhandari  1   2 ; FAITH-2 Investigators*
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Free article
Randomized Controlled Trial

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Gerard P Slobogean et al. J Orthop Trauma. 2020 Oct.
Free article

Abstract

Objective: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients.

Design: A pilot factorial randomized controlled trial.

Setting: Fifteen North American clinical sites.

Participants: Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation.

Intervention: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months).

Main outcome measurements: The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing.

Results: Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92).

Conclusions: These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic.

Level of evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

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References

    1. Pauyo T, Drager J, Albers A, et al. Management of femoral neck fractures in the young patient: a critical analysis review. World J Orthop. 2014;5:204–217.
    1. Slobogean GP, Sprague S, Bzovsky S, et al. Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients. Pilot Feasibility Stud. 2019;5:70.
    1. Malchau H, Herberts P, Eisler T, et al. The Swedish total hip replacement register. J Bone Joint Surg. 2002;84(suppl 2):2–20.
    1. Slobogean GP, Sprague SA, Scott T, et al. Management of young femoral neck fractures: is there a consensus. Injury. 2015;46:435–440.
    1. Sprague S, Petrisor B, Scott T, et al. What is the role of vitamin D supplementation in acute fracture patients? A systematic review and meta-analysis of the prevalence of hypovitaminosis D and supplementation efficacy. J Orthop Trauma. 2016;30:53–63.

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