Background
Multiple cancellous screws
Sliding hip screws
Inconclusive clinical evidence
Surgical management of hip fractures
Methods/Design
Pilot and vanguard phase
Study objectives
Study design
Randomization
Eligibility criteria
Patient recruitment and screening
Study interventions
Cancellous screw
Sliding hip screw
Standardization of procedures and peri-operative care
Study outcomes
Primary study endpoints
Secondary study endpoints
Adjudication of study events
Study follow-up
Radiographs & event forms | Pre-surgery | Surgery | Post-surgery | ||||||||||
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Screening | Enrolment | Baseline | (Day 0) | ≤ 48 hrs Post surgery | D/C | 1 wk (24 hrs-10 ds) | 10 wk (8-12 wks) | 6 mo (5-7 mos) | 9 mo (8-10 mos) | 12 mo (11-13 mos) | 18 mo (17-19 mos) | 24 mo (≥24 mos) | |
Radiographs
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Screening
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Informed consent
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Randomization
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Baseline
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Patient contact
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Pre-Op care
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Fracture characteristics
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Surgical report
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Post-Op care
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Clinic or telephone follow-up
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RS
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AE
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Hospital D/C
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Missed
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Follow-up
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Early W/D
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Protecting against sources of bias
Blinding
Surgeon expertise
Maximizing patient retention
Minimizing co-intervention and contamination
Statistical plan
Sample size determination
Baseline risk | |||||
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(Year 1)^ | Relative risk reduction | ||||
10% | 15% | 20% | 25% | 30% | |
20%
| 15.9% | 30.8% | 50.5% | 70.5% |
86.1%
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25%
| 19.6% | 38.7% | 61.6% |
81.5%
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93.5%
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30%
| 23.6% | 46.8% | 71.7% |
89.3%
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97.4%
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35%
| 28.2% | 55.2% |
80.3%
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94.5%
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99.1%
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40%
| 33.3% | 63.6% |
87.3%
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97.5%
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99.7%
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Baseline risk | |||||||
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(Year 1)^ | Relative risk reduction | ||||||
10% | 15% | 20% | 25% | 30% | 35v | 40% | |
15.5%
| 14.5% | 28.5% | 48.1% | 69.3% |
86.3%
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95.7%
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99.2%
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Statistical methods
Primary analysis
Secondary analysis
Subgroup analyses
Baseline risk | ||||||
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(Year 1)^ | Relative risk reduction | |||||
10% | 15% | 20% | 25% | 30% | 40%x | |
20%
| 12.0% | 22.1% | 36.3% | 53.2% | 70.1% |
93.0%
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25%
| 14.5% | 27.6% | 45.3% | 64.5% |
81.0%
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97.5%
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30%
| 17.2% | 33.5% | 45.3% | 74.4% |
88.9%
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99.2%
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35%
| 20.3% | 40.0% | 63.2% |
82.7%
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94.1%
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99.8%
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40%
| 23.8% | 47.0% | 71.7% |
89.2%
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97.2%
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100.0%
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Baseline risk | ||||||
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(Year 1)^ | Relative risk reduction | |||||
10% | 15% | 20% | 25% | 30% | 40% | |
20%
| 8.0% | 13.2% | 20.6% | 30.3% | 42.0% | 68.0% |
25%
| 9.3% | 16.0% | 25.5% | 37.8% | 51.3% | 79.0% |
30%
| 10.7% | 19.1% | 31.0% | 45.6% | 61.4% |
87.1%
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35%
| 12.3% | 22.6% | 36.3% | 53.7% | 70.3% |
92.7%
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40%
| 14.1% | 26.5% | 43.3% | 61.8% | 78.2% |
96.3%
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