Multimodal Decision Support for Perioperative Risk Stratification in Older Adults Undergoing Surgery for Fracture

July 26, 2026 updated by: Hui Zhang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Approximately 4,000-4,500 participants: 2,800-3,000 retrospective records and 1,200-1,500 prospectively enrolled participants

Study Type

Observational

Enrollment (Estimated)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Patients who have hip fracture or another eligible fracture requiring perioperative management and who undergo, or are scheduled to undergo, fracture surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
retrospective records
2,800-3,000 retrospective records
prospectively enrolled
1,200-1,500 prospectively enrolled participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality within 365 days after fracture surgery
Time Frame: 365 days after fracture surgery
365 days after fracture surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 8, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

July 26, 2026

First Submitted That Met QC Criteria

July 26, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perioperative Risk Stratificat

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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