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CompletedNCT05424575Updated Jun 21, 2022

Modified Fraility Index in Patients Undergoing Arthroplasty

An observational study in Frailty Syndrome and Postoperative Complications, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Ankara University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
145
Ages
45 Years to 85 Years
Sex
All
01

Study summary

The authors aimed to evaluate the relation between Modified Fraility Index (MFI) and postoperative complications (myocardial infarction, cardiac arrest, pulmonary embolism, septic shock, postoperative dialysis requirement, cerebrovascular event, reintubation, prolonged mechanical ventilation, surgical wound complications), duration of hospitalization, requirement for intensive care unit (ICU) admission and rehospitalization and 30th day mortality in patients undergoing arthroplasy.

Read the detailed description

Fraility index is calculated according to 70 parameters which are present in national surgical quality improvement programme (NSQIP) of American College of Surgeons. This model defines fraility as a cumulative effect of individual defects depending on clinical symptoms, disease states and disabilities which provides more accurate evaluation of aging. These 70 parameters present in NSQIP database were matched with 11 variables to create a modified fraility index.

There are 11 parametres in Modified Fraility Index (MFI) (Exacerbation of chronic obstructive pulmonary disease or history of pneumonia (within last 30 days), exacerbation of congestive heart failure (within last 30 days), diabetes mellitus, dependant functional status (partially or totally dependant), history of angina, percutaneous coronary intervention or coronary bypass grefting) (within last 30 days), medically treated hypertension, acute impaired sensorium, history of peripheral vascular disease, history of myocardial infarction (within last 6 months), cerebrovascular disease with neurological deficit, cerebrovascular disease without neurological deficit or transient ischemic attack (TIA).

Presence of one of the above MFI parameters has taken 1 point. The total point that each individual achieved according to the presence of the parameters is calculated and the total score divided by 11 is defined as MFI value.

145 patients aged between 45-85 who had undergone primary or revision total knee and hip arthroplasty were included to the current prospective study. In all patients MFI was calculated.

Patients were classified as nonfrail (MFI\<0,27), and frail patients (MFI≥0.27) according to MFI value.

All patients were followed up for 30 days during postoperative period. The presence of myocardial infarction, cardiac arrest, pulmonary embolism, septic shock, postoperative dialysis requirement, cerebrovascular event, reintubation, reoperation, prolonged mechanical ventilation, surgical wound complications; duration of hospitalization; requirement for intensive care unit (ICU) admission and rehospitalization and 30th day mortality were questioned.

02

Conditions studied

  • Frailty Syndrome
  • Postoperative Complications

Keywords

  • arthroplasty, fraility
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 145 is below the median of 223 across 496 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty

Inclusion criteria

patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty

Exclusion criteria

Exclusion Criteria:

Emergent surgery, patients aged below 45 and above 85, patients with cognitive dysfunction

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
145 participants (actual)
Patient registry
No

Groups and cohorts

  • Group Nonfrail (Group NF)

    Modified fraility index was calculated in all patients. Modified fraility index \< 0.27 were included to Group NF.

  • Group Frail (Group F)

    Modified fraility index was calculated in all patients. Modified fraility index ≥ 0.27 were included to Group F.

06

What researchers measure

Primary outcomes

  1. postoperative complications

    myocardial infarction, cardiac arrest, pulmonary embolism, septic shock, postoperative dialysis requirement, cerebrovascular event, reintubation, prolonged mechanical ventilation, surgical wound complications, duration of hospitalization, requirement for intensive care unit (ICU) admission and rehospitalization

    Time frame: 30 day

Secondary outcomes

  1. mortality

    30th day mortality

    Time frame: 30 day

07

Study locations

1 site
  • Ankara University Medical School Anesthesiology and ICU Department
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05424575
Lead sponsor
Ankara University
Responsible party
Sanem Cakar Turhan (Assoc. Prof., MD, Ankara University) — Principal investigator
First posted
Jun 21, 2022
Start date
Jul 20, 2020
Primary completion
Oct 20, 2020
Completion
Jan 25, 2021
Last update
Jun 21, 2022

Study contacts

Sanem Cakar Turhan, Assoc. Prof.
study chair · Ankara University Medical School Department of Anesthesiology and ICU
Leyla Alıbaylı, Specialist
principal investigator · Ankara University Medical School Department of Anesthesiology and ICU
Volkan Baytas, Specialist
principal investigator · Ankara University Medical School Department of Anesthesiology and ICU
Suheyla Karadag Erkoc, Specialist
principal investigator · Ankara University Medical School Department of Anesthesiology and ICU
Onat Bermede, Specialist
principal investigator · Ankara University Medical School Department of Anesthesiology and ICU
Hakan Kocaoglu, Assoc. Prof.
principal investigator · Ankara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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