Table 1.
Summary of all outcome measures.
| Outcome categories and measures | Definition | Assessment time points | |||
| Primary outcomes: fluoroscopy frequency | Total number of intraoperative fluoroscopic images acquired during the procedure | Intraoperative period | |||
| Secondary outcomes | |||||
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Neck-shaft angle | Angle between the femoral shaft axis and the femoral neck axis | Intraoperative period | ||
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Guide wire placement accuracy | Classification of guide wire arrangement as 3 parallel, 2 parallel, or nonparallel | Intraoperative period | ||
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Surgical duration | Time from skin incision to wound closure | Intraoperative period | ||
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Intraoperative blood loss | Total blood loss collected through suction | Intraoperative period | ||
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Fracture healing status | Fracture healing assessed by implant stability, disappearance of the fracture line, and absence of displacement | 1, 3, 6, and 12 months | ||
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Zarit Caregiver Burden Score | Assessment of caregiver burden | 1, 3, 6, and 12 months | ||
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Harris Hip Score | Assessment of hip function recovery | 1, 3, 6, and 12 months | ||
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36-Item Short Form Health Survey Score | Assessment of health-related quality of life | 1, 3, 6, and 12 months | ||
| Safety events | |||||
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Device-related adverse events | Adverse events directly related to the study device | All follow-ups | ||
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Serious adverse events | Events causing death, disability, or hospitalization | All follow-ups | ||
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Device defects | Malfunction or labeling error that may pose a health risk | Intraoperative and follow-up | ||
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General adverse events | Any unfavorable medical event regardless of causality | All follow-ups | ||