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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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Limiting loss to follow-up; Reference: Sprague S, Leece P, Bhandari M, Tornetta P, Schemitsch E, Swiontkowski M, SPRINT Investigators. Limiting loss to follow up in a multicentre randomized controlled trial in orthopaedic surgery. Controlled Clinical Trials. 2003;24:719–725.
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Figure 2: Limiting loss to follow-up; Reference: Sprague S, Leece P, Bhandari M, Tornetta P, Schemitsch E, Swiontkowski M, SPRINT Investigators. Limiting loss to follow up in a multicentre randomized controlled trial in orthopaedic surgery. Controlled Clinical Trials. 2003;24:719–725.

Mentions: Table 1 shows the schedule of study follow-up events. At each follow-up, study outcomes will be recorded. Any revision surgeries and adverse events will be recorded at each visit. Missed follow-up visits or early withdrawal will also be documented.We will only withdraw patients for the following scenarios: (1) Patients withdraw consent for participation; or (2) Patients are deemed lost to follow-up after the 24 month visit is overdue and all exhaustive measures have been taken to locate the patient (see Figure 2 for a detailed depiction of methodology for limiting loss to follow-up). We will document the reasons for patient withdrawal from the trial. For those patients who withdraw from other study activities, we will seek their approval to collect clinical data from their medical and hospital charts, and/or to contact them by telephone to ask about the primary and secondary outcomes. We will not withdraw patients even if the study protocol was not adhered to (e.g., patient received wrong treatment arm, occurrence of protocol deviations, missed follow-up visits, etc.).


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)

Limiting loss to follow-up; Reference: Sprague S, Leece P, Bhandari M, Tornetta P, Schemitsch E, Swiontkowski M, SPRINT Investigators. Limiting loss to follow up in a multicentre randomized controlled trial in orthopaedic surgery. Controlled Clinical Trials. 2003;24:719–725.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Limiting loss to follow-up; Reference: Sprague S, Leece P, Bhandari M, Tornetta P, Schemitsch E, Swiontkowski M, SPRINT Investigators. Limiting loss to follow up in a multicentre randomized controlled trial in orthopaedic surgery. Controlled Clinical Trials. 2003;24:719–725.
Mentions: Table 1 shows the schedule of study follow-up events. At each follow-up, study outcomes will be recorded. Any revision surgeries and adverse events will be recorded at each visit. Missed follow-up visits or early withdrawal will also be documented.We will only withdraw patients for the following scenarios: (1) Patients withdraw consent for participation; or (2) Patients are deemed lost to follow-up after the 24 month visit is overdue and all exhaustive measures have been taken to locate the patient (see Figure 2 for a detailed depiction of methodology for limiting loss to follow-up). We will document the reasons for patient withdrawal from the trial. For those patients who withdraw from other study activities, we will seek their approval to collect clinical data from their medical and hospital charts, and/or to contact them by telephone to ask about the primary and secondary outcomes. We will not withdraw patients even if the study protocol was not adhered to (e.g., patient received wrong treatment arm, occurrence of protocol deviations, missed follow-up visits, etc.).

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