ArticleOTA international : the open access journal of orthopaedic trauma2020
Fixation Using Alternative Implants for the Treatment of Hip Fractures: The feasibility of a multicenter 2 × 2 factorial randomized controlled trial evaluating surgical treatment and vitamin D supplementation in young femoral neck fracture patients.
Article in OTA international : the open access journal of orthopaedic trauma, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 3 citations in OpenAlex.
- Effect of Vitamin DJBMR plus · 2023Trial
- Cognitive Behavioural Therapy to Optimize Post-Operative Recovery (COPE): a randomized controlled feasibility trial in extremity fracture patients.Pilot and feasibility studies · 2025Article
Corrections and comments
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Authors and funding
15 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial.
designPilot trial.
settingTwenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. PATIENTS/
participantsNinety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation.
interventionEligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. MAIN OUTCOME MEASUREMENTS: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence).
resultsEighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months.
conclusionsDespite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.
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