NCT07490184

Brief Summary

The primary objective of this study is to establish a data repository that will be permissive of quality improvement studies/observations specific to postoperative mortality outcomes for geriatric patients with orthopedic injuries based on Orthopedic Hip Frailty Score and preoperative cardiac clearance predictors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
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

Study Progress15%
Feb 2026Feb 2028

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Number and Description of Study Sites/Total Number of Subjects Projected

    This study will include all geriatric trauma patients at Methodist Dallas Medical Center who meet registry inclusion and have an operative orthopedic injury. Enrollment will terminate once five years of data are captured: January 2018 through December 2023.

    5 years

Study Arms (1)

Total Number and Description of Study Sites/Total Number of Subjects Projected

This study will include all geriatric trauma patients at Methodist Dallas Medical Center who meet registry inclusion and have an operative orthopedic injury. Enrollment will terminate once five years of data are captured: January 2018 through December 2023.

Other: Medical/Phenotype Data Collection Procedures & Data to be Collected

Interventions

The Methodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality.

Total Number and Description of Study Sites/Total Number of Subjects Projected

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Among geriatric patients suffering from hip fractures, frailty is common and is associated with an increased risk of postoperative complications and morbidity with hip fracture surgery.

You may qualify if:

  • ≥60 years old Included in the Methodist Dallas Medical Center Trauma Registry Documented orthopedic injury with surgical management

You may not qualify if:

  • \<60 years old Prisoners, pregnant persons, or other protected populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Jennifer Burris, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

Kavya Mankulangara

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.

Shared Documents
STUDY PROTOCOL

Locations