Predicting Chronic Opioid Use Following Lower Extremity Joint Arthroplasty
Using Genomics and Gut Microbiome Data to Predict Postoperative Opioid Use in Patients Undergoing Lower Extremity Joint Replacement
1 other identifier
observational
1,000
1 country
1
Brief Summary
Personalized medicine is a concept in which medical care is individualized to a patient based on their unique characteristics, including comorbidities, demographics, genetics, and microbiome. After major surgery, some patients are at increased risk of opioid dependence. By identifying unique genetic and microbiome markers, clinicians may potentially identify individual risk factors for opioid dependence. By identifying these high risk patients early-on, personalized interventions may be applied to these patients in order to reduce the incidence of opioid-dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
July 13, 2021
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 27, 2023
July 1, 2023
2.3 years
July 13, 2021
July 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
3-month persistent opioid use
continual opioid use 3 months after surgery
3 months
3-month persistent post-surgical pain
continual pain at surgical site at 3 months
3 months
Secondary Outcomes (2)
Acute postoperative opioid use
48 hours
Acute postoperative pain
48 hours
Study Arms (2)
Persistent Opioid Use at 3 months
Patients who continue to use opioids about 3 months after their joint replacement surgery
No Persistent Opioid Use at 3 months
Patients who do not use opioids after about 3 months following joint replacement surgery
Eligibility Criteria
patients undergoing lower extremity joint replacement (i.e. total knee arthroplasty, total hip arthroplasty, hemiarthroplasty, unicompartmental knee replacement)
You may qualify if:
- patient undergoing unilateral knee or hip arthroplasty
You may not qualify if:
- refusal to consent
- lack of independent decision-making capacity
- inability to communicate effectively with research personnel
- if patient received antibiotics within the last 3 months prior to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego
La Jolla, California, 92037, United States
Biospecimen
we will receive pharmacogenomic (blood), microbiome, and microsomal exosome samples from subjects.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 23, 2021
Study Start
July 19, 2021
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
July 27, 2023
Record last verified: 2023-07