Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

Abstract

BackgroundHip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events.Methods/DesignFAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test.DiscussionThis study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials.Trial registrationThe FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

“…A previous report 8 details the trial objectives and methods. All participating centres obtained ethics approval.…”

“…10 Originally we determined that enrolment of 1500 patients would give the trial 81.5% power to detect a hazard ratio (HR) of 0.75 in the sliding hip screw group, at a two-sided alpha level of 0.05, on the assumption that the percentage of the primary outcome in the cancellous screws group would be 25% (appendix). 8 …”

“…On the basis of these data, we targeted a sample size of 1100 patients. A methods paper 8 published previously presents details of the sample size calculations and rationale.…”

A qualidade de vida após a fratura do colo femoral nos idosos: um estudo comparativo entre fixação interna e artroplastias

“…26 Durante a realização da presente pesquisa, estava em andamento um estudo internacional, multicêntrico e randomizado, conhecido pela sigla FAITH (Fixation using alternative implants for the treatment of hip fractures). 24,27 Por meio da avaliação da qualidade de vida e do resultado funcional relacionados a fraturas desviadas e não desviadas do colo femoral tratadas por métodos de osteossínteses, o estudo, quando concluído, pretende dar melhor embasamento científico para a indicação da escolha do paciente que deve ser submetido a essas modalidades de tratamento.…”

Study protocol: design and rationale for an exploratory phase II randomized controlled trial to determine optimal vitamin D3 supplementation strategies for acute fracture healing

“…All study outcomes (as defined above) will be documented on the case report forms (CRFs) at each follow-up visit. A 12-month follow-up was selected because it is a standard follow-up period for patients with tibial and femoral shaft fractures and it is a commonly used follow-up period for similar fracture trials [33, 39]. In addition, it is a commonly referenced time period for fracture healing complications requiring reoperation and will further inform decisions surrounding the larger, definitive RCT.…”