NCT05424575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 15, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

arthroplasty, fraility

Outcome Measures

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

    30 day

Secondary Outcomes (1)

  • mortality

    30 day

Study Arms (2)

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.

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical School Anesthesiology and ICU Department

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sanem Cakar Turhan, Assoc. Prof.

    Ankara University Medical School Department of Anesthesiology and ICU

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof., MD

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

July 20, 2020

Primary Completion

October 20, 2020

Study Completion

January 25, 2021

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations