NCT07736469

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Oct 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality within 365 days after fracture surgery

    365 days after fracture surgery

Study Arms (2)

retrospective records

2,800-3,000 retrospective records

prospectively enrolled

1,200-1,500 prospectively enrolled participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Department of Anesthesiology

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 30, 2026

Study Start (Estimated)

October 8, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

July 30, 2026

Record last verified: 2026-07