101. 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
- Author
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Andrea Howe, Lauren C. Hill, Diane Heels-Ansdell, Robert V O'Toole, Sheila Sprague, Darius Viskontas, Taryn Scott, Sofia Bzovsky, Mohit Bhandari, Greg E. Gaski, Gregory J. Della Rocca, Mauri Zomar, Gerard P. Slobogean, Krista M. Brown, Faith Investigators, Lehana Thabane, and Nathan N O'Hara
- Subjects
Adult ,medicine.medical_specialty ,Nonunion ,Population ,Pilot Projects ,Placebo ,law.invention ,03 medical and health sciences ,Fracture Fixation, Internal ,0302 clinical medicine ,Randomized controlled trial ,law ,Fracture fixation ,medicine ,Humans ,Orthopedics and Sports Medicine ,education ,Femoral neck ,030222 orthopedics ,education.field_of_study ,business.industry ,Hip Fractures ,Hazard ratio ,030208 emergency & critical care medicine ,General Medicine ,medicine.disease ,Confidence interval ,Surgery ,Femoral Neck Fractures ,medicine.anatomical_structure ,Treatment Outcome ,business - 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.
- Published
- 2020