Lower Limb FractureNCT07422025
Prognostic Value of Preoperative Frailty Assessment in Geriatric Lower Limb Orthopedic Surgery
An observational study of Lower Limb Fracture, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Lower Limb Fracture
- What is being tested?
- Preoperative Frailty Scoring
- How many people
- 149 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients younger than 65.
- Incomplete follow-up data or missing intraoperative records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lower Limb Fracture
- Being tested
- Preoperative Frailty Scoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Frailty ScoringOther
Data extraction of RAI and 5-mFI scores from medical records to correlate with 90-day postoperative outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Frail Group | Geriatric patients (aged 65+) identified as "frail" based on preoperative Risk Analysis Index (RAI) or 5-mFI scores. Receives: 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. Receives: Other: Preoperative Frailty Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days post-surgery
Secondary outcomes (1)
Correlation of Surgical Apgar Score (SAS) with Recovery
Evaluation of intraoperative parameters (blood loss, heart rate, blood pressure) via the SAS to predict the length of hospital stay.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb FractureStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Samy ElHammady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422025
- Sponsor's protocol ID
- RC 20.1.2026
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Merits of Preoperative Frailty Assessment of Geriatric Patients Undergoing Lower Limb Orthopedic Surgery.
- ClinicalTrials.gov ID
- NCT07422025
- Acronym / sponsor ID
- RC 20.1.2026
- Conditions
- Lower Limb Fracture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail Group | – | Other: Preoperative Frailty ScoringGeriatric patients (aged 65+) identified as "frail" based on preoperative Risk Analysis Index (RAI) or 5-mFI scores. |
| Non-Frail Group | – | Other: Preoperative Frailty ScoringGeriatric patients undergoing similar lower limb surgeries who are identified as "robust" or "non-frail" by the same assessment tools. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients younger than 65.
- Incomplete follow-up data or missing intraoperative records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Frailty ScoringData extraction of RAI and 5-mFI scores from medical records to correlate with 90-day postoperative outcomes. | Other | Frail Group, Non-Frail Group |
Primary outcome
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.
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.
1 secondary outcome
Correlation of Surgical Apgar Score (SAS) with Recovery
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Fracture, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Major Postoperative Complications (time frame: 90 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.