NCT07422025

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

28 days

First QC Date

February 8, 2026

Last Update Submit

February 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Major Postoperative Complications

    The number of participants who experienced one or more major postoperative complications, defined as Clavien-Dindo Grade III or higher.

    90 days post-surgery

  • Diagnostic Accuracy of the Risk Analysis Index (RAI)

    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

Secondary Outcomes (1)

  • Correlation of Surgical Apgar Score (SAS) with Recovery

    1 week

Study Arms (2)

Frail Group

Geriatric patients (aged 65+) identified as "frail" based on preoperative Risk Analysis Index (RAI) or 5-mFI scores.

Other: Preoperative Frailty Scoring

Non-Frail Group

Geriatric patients undergoing similar lower limb surgeries who are identified as "robust" or "non-frail" by the same assessment tools.

Other: Preoperative Frailty Scoring

Interventions

Data extraction of RAI and 5-mFI scores from medical records to correlate with 90-day postoperative outcomes.

Frail GroupNon-Frail Group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients younger than 65.
  • Incomplete follow-up data or missing intraoperative records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthopedic Surgery, Faculty of Medicine, Benha University.

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 19, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations