Logo image
Back
Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 x 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
Journal article   Open access   Peer reviewed

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 x 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Gerard P. Slobogean, Sheila Sprague, Sofia Bzovsky, Taryn Scott, Lehana Thabane, Diane Heels-Ansdell, Robert O'Toole, Andrea Howe, Greg E. Gaski, Lauren C. Hill, …
Injury, Vol.52(10), pp.3051-3059
10/01/2021
DOI: 10.1016/j.injury.2021.02.030
PMID: 33618847
url
https://doi.org/10.1016/j.injury.2021.02.030View
Published (Version of record) Open Access

Abstract

Purpose: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. Methods: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D 3 4,0 0 0 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed. (C) 2021 The Authors. Published by Elsevier Ltd.
 Orthopedics Surgery Critical Care Medicine Emergency Medicine General & Internal Medicine Life Sciences & Biomedicine Science & Technology

Details

Metrics

4 Record Views
Logo image