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Not yet recruiting NCT07736469

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

Observational Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Fracture. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • All-cause mortality within 365 days after fracture surgery [Time frame: 365 days after fracture surgery]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07736469 · Perioperative Risk Stratificat

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗