Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multi-Centre 2x2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
Abstract
OBJECTIVE
To assess whether fixation method and vitamin D supplementation impact the risk of patient important outcomes within 12 months of injury in non-geriatric femoral neck fracture patients.
DESIGN
Pilot factorial randomized controlled trial.
SETTING
15 North American clinical sites.
PARTICIPANTS
91 adults aged 18-60 years 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 4,000 IU daily versus placebo for 6 months).
MAIN OUTCOME MEASUREMENTS
The primary clinical outcome was a composite of patient important complications (re-operation, femoral head osteonecrosis, severe femoral neck malunion, nonunion). Secondary outcomes included fracture healing complications and radiographic fracture healing.
RESULTS
86 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 (HR) 0.90, 95% CI 0.40-2.02, p=0.80) and vitamin D supplementation treatment arms (HR 0.96, 95% CI 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 91 participants or records.
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