Frailty SyndromeNCT05424575
Modified Fraility Index in Patients Undergoing Arthroplasty
An observational study of Frailty Syndrome and Postoperative Complications, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Frailty Syndrome, Postoperative Complications
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 25 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty
Who may be able to join
- patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty
Who cannot join
- Emergent surgery, patients aged below 45 and above 85, patients with cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical School Anesthesiology and ICU Department
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty Syndrome, Postoperative Complications
- Keywords
- arthroplasty, fraility
- Medical subject headings
- Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 day
Secondary outcomes (1)
mortality
30th day mortality
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 Jul 2020
- Primary completion20 Oct 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanem Cakar Turhan, Ankara University
- Investigators
- Sanem Cakar Turhan, Assoc. Prof., Study chair, Ankara University Medical School Department of Anesthesiology and ICULeyla Alıbaylı, Specialist, Principal investigator, Ankara University Medical School Department of Anesthesiology and ICUVolkan Baytas, Specialist, Principal investigator, Ankara University Medical School Department of Anesthesiology and ICUSuheyla Karadag Erkoc, Specialist, Principal investigator, Ankara University Medical School Department of Anesthesiology and ICUOnat Bermede, Specialist, Principal investigator, Ankara University Medical School Department of Anesthesiology and ICUHakan Kocaoglu, Assoc. Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424575
- Sponsor's protocol ID
- AU I2-59-19
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38375705
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Fraility Index: Is it a Predictor for Early Postoperative Complications
- ClinicalTrials.gov ID
- NCT05424575
- Acronym / sponsor ID
- AU I2-59-19
- Conditions
- Frailty Syndrome, Postoperative Complications
- Keywords
- arthroplasty, fraility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty
Key inclusion criteria (1 listed)
- patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty
Key exclusion criteria (1 listed)
- Emergent surgery, patients aged below 45 and above 85, patients with cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
mortality
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 38375705Alibayli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanem Cakar Turhan, Assoc. Prof. study chair
Ankara University Medical School Department of Anesthesiology and ICU
Leyla Alıbaylı, Specialist principal investigator
Ankara University Medical School Department of Anesthesiology and ICU
Volkan Baytas, Specialist principal investigator
Ankara University Medical School Department of Anesthesiology and ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty Syndrome and Postoperative Complications, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.