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NCT Number: NCT07736469

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality within 365 days after fracture surgery

    Time frame: 365 days after fracture surgery

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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