Modified Fraility Index in Patients Undergoing Arthroplasty

Modified Fraility Index: Is it a Predictor for Early Postoperative Complications

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Frailty Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University Medical School Anesthesiology and ICU Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	30th day mortality	30 day

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Chair: Sanem Cakar Turhan, Assoc. Prof., Ankara University Medical School Department of Anesthesiology and ICU; Principal Investigator: Leyla Alıbaylı, Specialist, Ankara University Medical School Department of Anesthesiology and ICU; Principal Investigator: Volkan Baytas, Specialist, Ankara University Medical School Department of Anesthesiology and ICU; Principal Investigator: Suheyla Karadag Erkoc, Specialist, Ankara University Medical School Department of Anesthesiology and ICU; Principal Investigator: Onat Bermede, Specialist, Ankara University Medical School Department of Anesthesiology and ICU; Principal Investigator: Hakan Kocaoglu, Assoc. Prof., Ankara University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): October 20, 2020
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (ACTUAL): June 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: arthroplasty, fraility
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Postoperative Complications
• Other Study ID Numbers: AU I2-59-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No