Table 2.
Study procedures and visiting schedule.
| Study activities | Screening (day −7 to 0) | Surgery (day 0) | Postoperative follow-ups | |||||
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2 weeks | 1 month+2 weeks or −2 weeks | 3 months+2 weeks or −2 weeks | 6 months+2 weeks or −2 weeks | 12 months+2 weeks or −2 weeks | |
| Enrollment and consent | ||||||||
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Informed consent | ✓ |
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Demographic information | ✓ |
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Vital signs | ✓ | ✓ | ✓ |
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Medical history | ✓ |
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Laboratory tests | ✓ |
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Garden classification | ✓ |
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Time from injury to surgery | ✓ | ✓ |
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| Surgical details | ||||||||
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|
Intraoperative blood loss |
|
✓ |
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Duration of surgery |
|
✓ |
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|
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|
Guide pin implantation effect |
|
✓ |
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|
|
|
|
Intraoperative fluoroscopy (3-pin) |
|
✓ |
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|
|
|
|
|
|
Intraoperative fluoroscopy (total) |
|
✓ |
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|
|
|
|
|
Neck-shaft angle |
|
✓ |
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|
|
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|
Reduction quality (satisfaction) |
|
✓ |
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|
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|
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|
Garden alignment index |
|
✓ |
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Implant handling evaluation |
|
✓ |
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Surgery-related record |
|
✓ |
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|
| Clinical and imaging assessments | ||||||||
|
|
Radiography | ✓ |
|
✓ | ✓ | ✓ | ✓ | ✓ |
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|
Computed tomography scan | ✓ |
|
✓ |
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✓ | ✓ |
|
|
Harris Hip Score | ✓ |
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✓ | ✓ | ✓ | ✓ | ✓ |
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|
36-Item Short Form Health Survey quality-of-life score | ✓ |
|
✓ | ✓ | ✓ | ✓ | ✓ |
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|
Zarit Caregiver Burden Scale | ✓ |
|
✓ | ✓ | ✓ | ✓ | ✓ |
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|
Local physical examination | ✓ |
|
✓ | ✓ | ✓ | ✓ | ✓ |
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|
Rejection reaction |
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✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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|
Fracture healing |
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|
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✓ | ✓ | ✓ | ✓ |
|
|
Weight-bearing status |
|
|
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✓ | ✓ | ✓ | ✓ |
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|
Femoral neck shortening |
|
|
✓ |
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✓ | ✓ |
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|
Wound healing assessment |
|
|
✓ | ✓ |
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|
| Safety monitoring | ||||||||
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|
General adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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Serious adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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|
Device-related issues |
|
✓ |
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Concomitant medications or treatments | ✓ | ✓ | ✓ |
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