Pharmacogenetics for Pain Management in Joint Replacement Patients (PGx)

February 10, 2021 updated by: Anderson Orthopaedic Research Institute

Using Pharmacogenetics to Structure Individual Pain Management Protocols for Joint Replacement Patients

The purpose of this study is to determine the ability to use pharmacogenetic testing in a joint replacement practice to prescribe the most effective pain medicine for a specific patient.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Alexandria, Virginia, United States, 22307
        • Anderson Orthopaedic Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary total hip or total knee arthroplasty cases

Exclusion Criteria:

  • History of narcotic dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Subjects in this arm will receive the standard postoperative pain prescription protocol.
Active Comparator: Pharmacogenomics Guided Group
Subjects in this group will receive postoperative pain prescriptions based on the results of pharmacogenomic testing.
Diagnostic test: Pharmacogenomics Testing
The doctor will use genetic test results to prescribe medications that are a most effective for subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic variants
Time Frame: 10 days postoperative
Percent of subject with genetic variants affecting pain medication
10 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain levels
Time Frame: 10 days postoperatively
0-10 subjective pain scale
10 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anderson Orthopaedic Research Institute

Investigators

  • Principal Investigator: William Hamilton, MD, Anderson Orthopaedic Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AORI 2018-0100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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