Trial · NCT06452147
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days | during the first 7 postoperative days | Neurocognitive Disorders includes: 1. Postoperative delirium (POD) was mesaured by 3D-CAM; 2. Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members). Neurocognitive function is assessed at screening, postoperative day 3, and postoperative day 7. If discharge occurs on postoperative day 5 or 6, the final assessment is performed on the day of discharge; if discharge occurs on postoperative day 4, no repeat cognitive assessment is performed. A participant with postoperative delirium and/or postoperative neurocognitive decline is classified as positive for the primary outcome. |
| Secondary | Subtypes, severity, and duration of delirium | during the first 7 postoperative days | Using CAM-S, and in units of days from the onset of delirium symptoms to the disappearance of symptoms or when the patient is discharged. |
| Secondary | Neurocognitive decline in postoperative 7 days | during the first 7 postoperative days | Neurocognitive decline was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members. |
| Secondary | Delayed neurocognitive recovery during 30 postoperative days | Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days. | This was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains(1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members. |
| Secondary | Hospital Anxiety and Depression Scale (HADs) | At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month. | |
| Secondary | Acute pain before and after surgery | Before surgery and on postoperative days 1, 2, and 3. | Using Visual Analogue Scale (VAS) |
| Secondary | Length of hospitalization | days from admission to discharge, an average of 7 days | |
| Secondary | Incidence of important intraoperative adverse events requiring treatment | During anesthesia on the day of surgery. | Important intraoperative adverse events are defined as adverse events requiring treatment. |
| Secondary | Complications (except cognitive impairment) | during postoperation 30 days | including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc. |
| Secondary | In-hospital and 30-day mortality | During hospitalization and within 30 days after surgery. | |
| Secondary | Days at home up to 30 days after surgery (DAH30) | up to 30 days after surgery | |
| Secondary | Score of EuroQol Five Dimensions Questionnaire (EQ-5D) | 1 week before fracture (retrospective assessment), and 1, 3, 6, 9, and 12 months after surgery. | Quality of life will be assessed using the EuroQol Five Dimensions Questionnaire (EQ-5D). Prefracture quality of life will be assessed retrospectively for the week before fracture. |
| Secondary | Incidence of postoperative Neurocognitive Disorders (NCD) | Up to 12 months after surgery. | Postoperative neurocognitive disorder will be determined as a binary outcome according to the prespecified neurocognitive assessment framework. Cognitive assessments, including the Mini-Mental State Examination, Montreal Cognitive Assessment, multidomain neuropsychological tests, and patient- or caregiver-reported cognitive change, will be integrated according to the prespecified criteria to determine whether postoperative neurocognitive disorder is present. The reported outcome is the proportion of participants with postoperative neurocognitive disorder. |
| Secondary | Severity of postoperative Neurocognitive Disorders (NCD) | At 12 months after surgery | |
| Secondary | Type of postoperative Neurocognitive Disorders (NCD) | within 1 year after surgery (long-term) | Using Hachinski Ischemic Scale (HIS) combined with clinical symptoms and auxiliary examination to mesaure the type of postoperative NCD. HIS ≥7 was considered as vascular cognitive impairment. |
| Secondary | Instrumental Activities of Daily Living (IADL) | At screening for the week before fracture, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative months 3, 6, 9, and 12. | |
| Secondary | 1-year all-cause mortality | 1-year after surgery | |
| Secondary | Health economic outcomes | During hospitalization; from hospital discharge to the 1-month follow-up; and for each interval from the previous follow-up visit to the 3-, 6-, 9-, and 12-month follow-up visits. | Health economic outcomes include direct medical costs, direct nonmedical costs, and indirect costs. Direct medical costs include anesthesia and related costs, surgical treatment costs, medication and biological product costs, diagnosis-related costs, supportive treatment costs, rehabilitation costs, blood and blood product costs, and consumable material costs. Direct nonmedical costs include paid caregiver costs, transportation costs, and accommodation costs related to medical care. Indirect costs mainly include productivity losses of family members or unpaid caregivers due to accompanying or caring for the participant. |
| Other | Incidence of adverse events | From enrollment to hospital discharge, an average of 7 days. | We will collect the following known potential risks of general and local anesthesia from the start of the intervention to the subject's discharge and assess the overall incidence: 1. cardiopulmonary resuscitation; 2. Malignant hyperthermia or anaphylaxis; 3. Aspiration pneumonia ; 4. Epidural hematoma requiring surgical intervention within 24 hours after regional anesthesia; 5. Lower-limb paralysis lasting more than 24 hours after regional anesthesia or nerve block; 6. Unplanned postoperative mechanical ventilation lasting more than 6 hours in patients who did not require mechanical ventilation before surgery; 7. Other adverse events during postoperative hospitalization. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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