Clinical trial NCT05424575: Modified Fraility Index in Patients Undergoing Arthroplasty
Official title: Modified Fraility Index: Is it a Predictor for Early Postoperative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty Syndrome
Postoperative Complications
Keywords: arthroplasty, fraility
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 145
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative complications
timeFrame: 30 day
Secondary outcomes:
measure: mortality
timeFrame: 30 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical School Anesthesiology and ICU Department
Study officials:
affiliation: Ankara University Medical School Department of Anesthesiology and ICU
name: Sanem Cakar Turhan, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Ankara University Medical School Department of Anesthesiology and ICU
name: Leyla Alıbaylı, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Medical School Department of Anesthesiology and ICU
name: Volkan Baytas, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Medical School Department of Anesthesiology and ICU
name: Suheyla Karadag Erkoc, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Medical School Department of Anesthesiology and ICU
name: Onat Bermede, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Hakan Kocaoglu, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: