Modified Fraility Index in Patients Undergoing Arthroplasty

NCT ID: NCT05424575

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Syndrome Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Nonfrail (Group NF)

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

No interventions assigned to this group

Group Frail (Group F)

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sanem Cakar Turhan

Assoc. Prof., MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sanem Cakar Turhan, Assoc. Prof.

Role: STUDY_CHAIR

Ankara University Medical School Department of Anesthesiology and ICU

Leyla Alıbaylı, Specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara University Medical School Department of Anesthesiology and ICU

Volkan Baytas, Specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara University Medical School Department of Anesthesiology and ICU

Suheyla Karadag Erkoc, Specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara University Medical School Department of Anesthesiology and ICU

Onat Bermede, Specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara University Medical School Department of Anesthesiology and ICU

Hakan Kocaoglu, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara University Medical School Anesthesiology and ICU Department

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Alibayli L, Cakar Turhan KS, Baytas V, Karadag Erkoc S, Bermede O, Kocaoglu H. Modified frailty index (mFI): is it a predictor for early postoperative complications in arthroplasty surgery? Eur Rev Med Pharmacol Sci. 2024 Feb;28(3):1002-1014. doi: 10.26355/eurrev_202402_35336.

Reference Type DERIVED
PMID: 38375705 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AU I2-59-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Frailty and Postoperative Shock
NCT02669927 COMPLETED