NCT04827888

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76,189

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 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

January 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

March 30, 2021

Last Update Submit

April 1, 2021

Conditions

Keywords

weightorthopedic surgeryBMIPost-Op Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • mortality

    within the 30 days following the surgery

  • wound

    within the 30 days following the surgery

  • cardiac

    within the 30 days following the surgery

  • respiratory

    within the 30 days following the surgery

  • urinary

    within the 30 days following the surgery

  • +5 more secondary outcomes

Study Arms (5)

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

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

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

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

moderately-to-severely obese

patients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2

Procedure: Orthopaedic surgery

Interventions

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 obesemoderately-to-severely obesenormal-weightoverweightunderweight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Representative of the population from ACS-NSQIP

You may not qualify if:

  • All patients who have undergone any of the 25 most common orthopedic procedures as primary procedure as identified through the CPT codes
  • All patients whose BMI was not reported

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, 11-236, Lebanon

Location

MeSH Terms

Conditions

ObesityBody WeightPostoperative Complications

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Muhyeddine Al-Taki

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Surgery

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2015

Study Completion

December 31, 2020

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data

Locations