Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Orthopedic Procedures
• Intervention / Treatment: Procedure: Orthopaedic surgery

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 Type: Observational
• Enrollment (Actual): 76189

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 11-236
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Representative of the population from ACS-NSQIP

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• All patients whose BMI was not reported

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
underweight; patients who underwent one of the 25 common orthopaedic surgeries and have a body mass index (BMI) of <18.5kg/m2	Procedure: Orthopaedic 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).
normal-weight; patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 18.5kg/m2 and 24.9kg/m2	Procedure: Orthopaedic 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).
overweight; patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 25kg/m2 and 29.9kg/m2	Procedure: Orthopaedic 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).
mildly obese; patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 30kg/m2 and 34.9kg/m2	Procedure: Orthopaedic 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).
moderately-to-severely obese; patients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2	Procedure: Orthopaedic 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within the 30 days following the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	odds ratio of mortality within the 30-days following the surgery for each BMI group as compared to normal-weight group	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	within the 30 days following the surgery
cardiac	specific morbidity of cardiac complication for each BMI group as compared to normal-weight group	within the 30 days following the surgery
respiratory	odds ratio of specific morbidity of respiratory complication	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	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	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	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	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	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	within the 30 days following the surgery

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Muhyeddine Al-Taki, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: BMI; orthopedic surgery; weight; Post-Op Complication
• Other Study ID Numbers: 20210330BMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No