FractureNCT07736469
Multimodal Decision Support for Perioperative Risk Stratification in Older Adults Undergoing Surgery for Fracture
An observational study of Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial summary
The goal of this observational study is to establish a standardized multicenter cohort and develop and validate clinically interpretable models for perioperative risk stratification, brain-state risk prediction, objective pain assessment, sleep-pain-delirium association analysis, and longer-term prognosis.The main… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fracture
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 30 Jun 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years or older who have hip fracture or another eligible fracture requiring perioperative management and who undergo, or are scheduled to undergo, fracture surgery
Who may be able to join
- Patients who have hip fracture or another eligible fracture requiring perioperative management and who undergo, or are scheduled to undergo, fracture surgery
Who cannot join
None listed.
About this study
The goal of this observational study is to establish a standardized multicenter cohort and develop and validate clinically interpretable models for perioperative risk stratification, brain-state risk prediction, objective pain assessment, sleep-pain-delirium association analysis, and longer-term prognosis.The main questions it aims to answer are:
Can clinically interpretable predictive models be developed for perioperative risk stratification and brain-state changes? What are the associations among objective pain measures, sleep quality, and postoperative delirium? Are these perioperative factors associated with longer-term patient outcomes? This is a multicenter cohort study without a separate comparator group. Participants will undergo routine perioperative clinical assessments and standardized follow-up evaluations according to the study protocol.
Read the detailed description
Approximately 4,000-4,500 participants: 2,800-3,000 retrospective records and 1,200-1,500 prospectively enrolled participants
- Conditions
- Fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retrospective records | 2,800-3,000 retrospective records | |
| prospectively enrolled | 1,200-1,500 prospectively enrolled participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality within 365 days after fracture surgery
Measured: 365 days after fracture surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zhang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736469
- Sponsor's protocol ID
- Perioperative Risk Stratificat
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Decision Support for Perioperative Risk Stratification in Older Adults Undergoing Surgery for Fracture
- ClinicalTrials.gov ID
- NCT07736469
- Acronym / sponsor ID
- Perioperative Risk Stratificat
- Conditions
- Fracture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to establish a standardized multicenter cohort and develop and validate clinically interpretable models for perioperative risk stratification, brain-state risk prediction, objective pain assessment, sleep-pain-delirium association analysis, and longer-term prognosis.The main questions it aims to answer are:
Can clinically interpretable predictive models be developed for perioperative risk stratification and brain-state changes? What are the associations among objective pain measures, sleep quality, and postoperative delirium? Are these perioperative factors associated with longer-term patient outcomes? This is a multicenter cohort study without a separate comparator group. Participants will undergo routine perioperative clinical assessments and standardized follow-up evaluations according to the study protocol.
Detailed description
Approximately 4,000-4,500 participants: 2,800-3,000 retrospective records and 1,200-1,500 prospectively enrolled participants
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective records | – | –2,800-3,000 retrospective records |
| prospectively enrolled | – | –1,200-1,500 prospectively enrolled participants |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older who have hip fracture or another eligible fracture requiring perioperative management and who undergo, or are scheduled to undergo, fracture surgery
Key inclusion criteria (1 listed)
- Patients who have hip fracture or another eligible fracture requiring perioperative management and who undergo, or are scheduled to undergo, fracture surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality within 365 days after fracture surgery
Time frame: 365 days after fracture surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 365 days after fracture surgery (time frame: 365 days after fracture surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.