- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422025
Prognostic Value of Preoperative Frailty Assessment in Geriatric Lower Limb Orthopedic Surgery
February 19, 2026 updated by: Adel Samy ElHammady, Benha University
The Merits of Preoperative Frailty Assessment of Geriatric Patients Undergoing Lower Limb Orthopedic Surgery.
This retrospective study evaluates the effectiveness of frailty assessment tools-specifically the Risk Analysis Index (RAI) and the 5-Item Modified Frailty Index (5-mFI)-in predicting postoperative outcomes for elderly patients undergoing lower limb orthopedic surgery.
The study seeks to determine if these preoperative scores can accurately identify patients at higher risk for 90-day mortality and major complications.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Al Qalyoubia
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Banhā, Al Qalyoubia, Egypt, 13511
- Benha University
-
-
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
Non-Probability Sample
Study Population
The study population consists of geriatric patients aged 65 years and older who underwent major lower limb orthopedic surgeries (such as hip or knee arthroplasty or fracture fixation) at the participating orthopedic departments.
The cohort includes individuals with varying degrees of preoperative physical reserve, categorized into frail, pre-frail, and non-frail groups using validated assessment tools.
This population represents a high-risk surgical demographic characterized by multiple comorbidities and age-related physiological decline, requiring detailed perioperative data analysis.
Description
Inclusion Criteria:
- Geriatric patients (aged 65 years and older).
- Underwent lower limb orthopedic surgery (e.g., hip or knee arthroplasty, fracture fixation).
- Availability of complete perioperative medical records.
Exclusion Criteria:
- Patients younger than 65.
- Incomplete follow-up data or missing intraoperative records.
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 |
Intervention / Treatment |
|---|---|
|
Frail Group
Geriatric patients (aged 65+) identified as "frail" based on preoperative Risk Analysis Index (RAI) or 5-mFI scores.
|
Data extraction of RAI and 5-mFI scores from medical records to correlate with 90-day postoperative outcomes.
|
|
Non-Frail Group
Geriatric patients undergoing similar lower limb surgeries who are identified as "robust" or "non-frail" by the same assessment tools.
|
Data extraction of RAI and 5-mFI scores from medical records to correlate with 90-day postoperative outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Accuracy of the Risk Analysis Index (RAI)
Time Frame: 90 days post-surgery
|
The Area Under the Receiver Operating Characteristic (ROC) curve used to determine the predictive performance of the RAI score for 90-day mortality.
|
90 days post-surgery
|
|
Percentage of Participants With Major Postoperative Complications
Time Frame: 90 days post-surgery
|
The number of participants who experienced one or more major postoperative complications, defined as Clavien-Dindo Grade III or higher.
|
90 days post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of Surgical Apgar Score (SAS) with Recovery
Time Frame: 1 week
|
Evaluation of intraoperative parameters (blood loss, heart rate, blood pressure) via the SAS to predict the length of hospital stay.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 1, 2026
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
February 8, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
February 23, 2026
Last Update Submitted That Met QC Criteria
February 19, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- RC 20.1.2026
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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