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Completed

NCT Number: NCT05424575

Modified Fraility Index in Patients Undergoing Arthroplasty

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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Medical School Anesthesiology and ICU Department

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postoperative complications

    Time frame: 30 day

    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

Secondary outcomes

  1. mortality

    Time frame: 30 day

    30th day mortality

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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