Orthopedic ProceduresBMIORTHONCT04827888
Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures
An observational study of Orthopedic Procedures and Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Procedures, Obesity
- What is being tested?
- Orthopaedic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 76,189 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2012to 31 Dec 2020
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Representative of the population from ACS-NSQIP
Who may be able to join
- The inclusion and exclusion criteria are the same as that of ACS-NSQIP database.
- All patients who have undergone any of the 25 most common orthopedic procedures as primary procedure as identified through the CPT codes
Who cannot join
- All patients whose BMI was not reported
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of BMI On Thirty-day Postoperative Morbidities And Mortality For The Most Common Orthopaedic Procedures
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries using a retrospective cohort study design. The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities.
Read the detailed description
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the procedure specific, independent-effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries.
The study is a retrospective cohort study. The subjects will be the individuals undergoing one of first 25 most commonly performed orthopedic surgeries, whose information is derived form the de-identified patients' data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. The primary outcome will be composite post-operative morbidity. Specific morbidities will also be evaluated including cardiovascular, vascular and renal complications, length-of-stay (LOS), and the need for re-intervention and readmission, as well as 30-day mortality. Descriptive statistics and multivariable regression models will assess the independent-effect of BMI on outcomes.
The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities. The surgeon will be able to better counsel obese patients and devise a better surgical plan to prevent or deal with the expected outcomes.
- Conditions
- Orthopedic Procedures, Obesity
- Being tested
- Orthopaedic surgery
- Keywords
- weight, orthopedic surgery, BMI, Post-Op Complication
- Medical subject headings
- Obesity, Body Weight, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic surgeryProcedure or surgery
One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
| Study group | Role | What they receive |
|---|---|---|
| underweight | patients who underwent one of the 25 common orthopaedic surgeries and have a body mass index (BMI) of <18.5kg/m2 Receives: Procedure: Orthopaedic surgery | |
| normal-weight | patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 18.5kg/m2 and 24.9kg/m2 Receives: Procedure: Orthopaedic surgery | |
| overweight | patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 25kg/m2 and 29.9kg/m2 Receives: Procedure: Orthopaedic surgery | |
| mildly obese | patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 30kg/m2 and 34.9kg/m2 Receives: Procedure: Orthopaedic surgery | |
| moderately-to-severely obese | patients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2 Receives: Procedure: Orthopaedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite morbidity
Composite morbidity is defined as the presence of any of the specific morbidities during the 30-days following surgery as recorded in the ACS-NSQIP database. The odds ratio of composite morbidity for each BMI group will be calculated as compared to normal-weight group.
Measured: within the 30 days following the surgery
Secondary outcomes (10)
mortality
odds ratio of mortality within the 30-days following the surgery for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
wound
odds ratio of specific morbidity of surgical wound for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
cardiac
specific morbidity of cardiac complication for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
respiratory
odds ratio of specific morbidity of respiratory complication
Measured: within the 30 days following the surgery
urinary
odds ratio of specific morbidity of urinary complication for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
neurological
odds ratio of specific morbidity of neurological (CNS) complication for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
thromboembolism
odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
sepsis
odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
bleeding
odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
Re-op
odds ratio of need for re-admission/re-operation for each BMI group as compared to normal-weight group
Measured: within the 30 days following the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProceduresStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 76,189 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhyeddine Al-Taki, American University of Beirut Medical Center
- Investigators
- Muhyeddine Al-Taki, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827888
- Sponsor's protocol ID
- 20210330BMI
- Acronym
- BMIORTHO
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of BMI On Thirty-day Postoperative Morbidities And Mortality For The Most Common Orthopaedic Procedures
- ClinicalTrials.gov ID
- NCT04827888
- Acronym / sponsor ID
- BMIORTHO / 20210330BMI
- Conditions
- Orthopedic Procedures, Obesity
- Keywords
- weight, orthopedic surgery, BMI, Post-Op Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76,189 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Apr 2021 (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.
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries using a retrospective cohort study design. The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities.
Detailed description
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the procedure specific, independent-effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries.
The study is a retrospective cohort study. The subjects will be the individuals undergoing one of first 25 most commonly performed orthopedic surgeries, whose information is derived form the de-identified patients' data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. The primary outcome will be composite post-operative morbidity. Specific morbidities will also be evaluated including cardiovascular, vascular and renal complications, length-of-stay (LOS), and the need for re-intervention and readmission, as well as 30-day mortality. Descriptive statistics and multivariable regression models will assess the independent-effect of BMI on outcomes.
The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities. The surgeon will be able to better counsel obese patients and devise a better surgical plan to prevent or deal with the expected outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| underweight | – | Procedure: Orthopaedic surgerypatients who underwent one of the 25 common orthopaedic surgeries and have a body mass index (BMI) of <18.5kg/m2 |
| normal-weight | – | Procedure: Orthopaedic surgerypatients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 18.5kg/m2 and 24.9kg/m2 |
| overweight | – | Procedure: Orthopaedic surgerypatients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 25kg/m2 and 29.9kg/m2 |
| mildly obese | – | Procedure: Orthopaedic surgerypatients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 30kg/m2 and 34.9kg/m2 |
| moderately-to-severely obese | – | Procedure: Orthopaedic surgerypatients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representative of the population from ACS-NSQIP
Key inclusion criteria (2 listed)
- The inclusion and exclusion criteria are the same as that of ACS-NSQIP database.
- All patients who have undergone any of the 25 most common orthopedic procedures as primary procedure as identified through the CPT codes
Key exclusion criteria (1 listed)
- All patients whose BMI was not reported
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopaedic surgeryOne of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486). | Procedure or surgery | mildly obese, moderately-to-severely obese, normal-weight, overweight, underweight |
Primary outcome
Composite morbidity
Time frame: within the 30 days following the surgery
Composite morbidity is defined as the presence of any of the specific morbidities during the 30-days following surgery as recorded in the ACS-NSQIP database. The odds ratio of composite morbidity for each BMI group will be calculated as compared to normal-weight group.
10 secondary outcomes
mortality
Time frame: within the 30 days following the surgery
wound
Time frame: within the 30 days following the surgery
cardiac
Time frame: within the 30 days following the surgery
respiratory
Time frame: within the 30 days following the surgery
urinary
Time frame: within the 30 days following the surgery
neurological
Time frame: within the 30 days following the surgery
thromboembolism
Time frame: within the 30 days following the surgery
sepsis
Time frame: within the 30 days following the surgery
bleeding
Time frame: within the 30 days following the surgery
Re-op
Time frame: within the 30 days following the surgery
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 5 Apr 2021.
- Individual participant dataSharing planned: No. Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
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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.
Muhyeddine Al-Taki principal investigator
American University of Beirut Medical Center
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 Orthopedic Procedures and Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 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 5 Apr 2021. 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 Lebanon. 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?
Composite morbidity (time frame: within the 30 days following the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2021.