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age>18 | Yes
|
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Fracture time <2 weeks | Yes
|
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surgical treatment | Yes
|
|
Meet at least one of the following conditions | No
|
|
name | 王爱峰 |
|
Gender | male
|
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Age | 41 岁 |
|
height | 170 cm |
|
weight | 66 kg |
|
BMI | 22.84 |
|
occupation | manual work
|
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smoking | No
|
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alcohol intake | No
|
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osteoporosis | No
|
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malnutrition | No
|
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anemia | No
|
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diabetes | No
|
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history of hormone drugs | No
|
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history of malignant tumor treated with radiotherapy and chemotherapy | No
|
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fracture site | Femoral shaft fracture
|
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Surgical method | intramedullary nail
|
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Injury mechanism | falling injury
|
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open fracture or not | No
|
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Left or right | left
|
|
AO classification | 32B3 |
|
VAS (before operation) | 7 分 |
|
operation date | 2022-4-7 日 |
|
How many times needed to lock the first hole successfully | 1
|
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How many times needed to lock the second hole successfully | 1
|
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How many times needed to screw the first cannulated screw | The operation was not performed
|
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How many times needed to screw the second cannulated screw | The operation was not performed
|
|
How many times needed to screw the third cannulated screw | The operation was not performed
|
|
operative time | min |
|
radiation exposure time | sec |
|
Amount of bleeding | mL |
- 6 weeks after surgery (±2 weeks)
- 12 weeks after surgery (±2 weeks)
- 24 weeks after surgery (±2 weeks)
- 1 year after surgery (±2 weeks)
|
Follow up date | 2022-6-15 |
|
temperature | 36.5 ℃ |
|
blood pressure | 123/75 mm Hg |
|
heart rate | 68 次/分 |
|
respiratory rate | 19 次/分 |
|
Whether the wound is healed or not | Class A
|
|
X-ray results | Callus began to form
|
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No local tenderness, no percussion pain | Yes
|
|
No local abnormal activity | No
|
|
X-ray shows blurred fracture line with continuous callus passing through fracture line | Yes
|
|
In the case of lifting external fixation, the lower limbs can not walk continuously for 3 minutes, not less than 30 steps | No
|
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Meet the above clinical healing standards | No
|
|
X-ray shows trabeculae crossing the fracture line | No
|
|
VAS score |
|
|
Harris score |
|
|
adverse event | 无 |
|
Follow up date | 2022-7-18 |
|
temperature | 36.5 ℃ |
|
blood pressure | 126/82 mmHg |
|
heart rate | 72 次/分 |
|
respiratory rate | 17 次/分 |
|
Whether the wound is healed or not | Class A
|
|
X-ray results | Callus began to form
|
|
No local tenderness, no percussion pain | No
|
|
No local abnormal activity | No
|
|
X-ray shows blurred fracture line with continuous callus passing through fracture line | Yes
|
|
In the case of lifting external fixation, the lower limbs can not walk continuously for 3 minutes, not less than 30 steps | No
|
|
Meet the above clinical healing standards | No
|
|
X-ray shows trabeculae crossing the fracture line | Yes
|
|
VAS score |
|
|
Harris score |
|
|
adverse event |
|
|
Follow up date |
|
|
temperature | ℃ |
|
blood pressure | mmHg |
|
heart rate | 次/分 |
|
respiratory rate | 次/分 |
|
Whether the wound is healed or not |
|
X-ray results |
|
No local tenderness, no percussion pain | |
|
No local abnormal activity | |
|
X-ray shows blurred fracture line with continuous callus passing through fracture line | |
|
In the case of lifting external fixation, the lower limbs can not walk continuously for 3 minutes, not less than 30 steps |
|
Meet the above clinical healing standards | |
|
X-ray shows trabeculae crossing the fracture line |
|
VAS score |
|
|
Harris score |
|
|
adverse event |
|
|
Follow up date |
|
|
temperature | ℃ |
|
blood pressure | mmHg |
|
heart rate | 次/分 |
|
respiratory rate | 次/分 |
|
Whether the wound is healed or not |
|
X-ray results |
|
No local tenderness, no percussion pain | |
|
No local abnormal activity | |
|
X-ray shows blurred fracture line with continuous callus passing through fracture line | |
|
In the case of lifting external fixation, the lower limbs can not walk continuously for 3 minutes, not less than 30 steps |
|
Meet the above clinical healing standards | |
|
X-ray shows trabeculae crossing the fracture line |
|
VAS score |
|
|
Harris score |
|
|
adverse event |
|
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End date of subject trial |
|
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Whether the subject completed the test | |
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Reasons for subjects to terminate the study |
|
Adverse events | |
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Description of adverse events |
|
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Date and time of adverse event occurrence |
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Severity of adverse events | |
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Whether it is related to test equipment | |
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Impact on the test | |
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Action taken for adverse events | |
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Outcomes of adverse events | |
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Whether it is a serious adverse event |