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    Fixation using alternative implants for the treatment of hip fractures (FAITH-2): Design and rationale for a pilot multi-centre 2 x 2 factorial randomized controlled trial in young femoral neck fracture patients

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    Author
    Slobogean, G.P.
    Sprague, S.
    Bzovsky, S.
    Date
    2019
    Journal
    Pilot and Feasibility Studies
    Publisher
    BioMed Central Ltd.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1186/s40814-019-0458-x
    Abstract
    Background: Femoral neck fractures in patients . 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods: We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 ~ 2 factorial design in 60 patients aged 18.60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion: Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations. Trial registration: The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant. Copyright The Author(s).
    Sponsors
    Supported by research grants from the Canadian Institutes of Health Research (MOP-130271 and MTO-130912), McMaster Surgical Associates, and Hamilton Health Sciences (NIF 13329).
    Keyword
    Clinical protocols
    Femoral neck fractures
    Fracture fixation
    internal
    Randomized controlled trial
    Vitamin D
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85083183811&doi=10.1186%2fs40814-019-0458-x&partnerID=40&md5=f902f6924b71e6fae2ec933a79aa01d3; http://hdl.handle.net/10713/12657
    ae974a485f413a2113503eed53cd6c53
    10.1186/s40814-019-0458-x
    Scopus Count
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