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.
Journal
Journal of orthopaedic trauma
ISSN: 1531-2291
Titre abrégé: J Orthop Trauma
Pays: United States
ID NLM: 8807705
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
pubmed:
1
8
2020
medline:
22
6
2021
entrez:
1
8
2020
Statut:
ppublish
Résumé
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. A pilot factorial randomized controlled trial. Fifteen North American clinical sites. Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation. 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). 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. 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). 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. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Identifiants
pubmed: 32732587
doi: 10.1097/BOT.0000000000001773
pii: 00005131-202010000-00004
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
524-532Références
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