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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.

- BMC Musculoskelet Disord (2014)

Bottom Line: 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.Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw.Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: Hip 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/design: FAITH 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.

Discussion: This 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 registration: The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

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Related in: MedlinePlus

Recruitment schedule (Baseline radiographs & Data collection).
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Related In: Results  -  Collection

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Figure 1: Recruitment schedule (Baseline radiographs & Data collection).

Mentions: Data will be collected from academic hospitals in Australia, Canada, England, Germany, India, Norway, The Netherlands, and The United States. A complete list of clinical sites can be obtained from the corresponding author upon request. All patients presenting to participating surgeons with a diagnosed femoral neck fracture will be screened. Figure 1 shows the patient identification and screening procedures. Informed consent will be obtained from all eligible patients by qualified clinical site personnel who are knowledgeable about the study. If a patient lacks capacity and is deemed unable to consent, informed consent may be obtained from the patient’s legally authorized representative.


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.

- BMC Musculoskelet Disord (2014)

Recruitment schedule (Baseline radiographs & Data collection).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4230242&req=5

Figure 1: Recruitment schedule (Baseline radiographs & Data collection).
Mentions: Data will be collected from academic hospitals in Australia, Canada, England, Germany, India, Norway, The Netherlands, and The United States. A complete list of clinical sites can be obtained from the corresponding author upon request. All patients presenting to participating surgeons with a diagnosed femoral neck fracture will be screened. Figure 1 shows the patient identification and screening procedures. Informed consent will be obtained from all eligible patients by qualified clinical site personnel who are knowledgeable about the study. If a patient lacks capacity and is deemed unable to consent, informed consent may be obtained from the patient’s legally authorized representative.

Bottom Line: 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.Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw.Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: Hip 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/design: FAITH 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.

Discussion: This 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 registration: The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

Show MeSH
Related in: MedlinePlus