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Pharmacogenetics for Pain Management in Joint Replacement Patients (PGx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03772535
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2018
Last Update Posted : August 1, 2019
Information provided by (Responsible Party):
Anderson Orthopaedic Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty Complications Diagnostic Test: Pharmacogenomics Testing Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Using Pharmacogenetics to Structure Individual Pain Management Protocols for Joint Replacement Patients
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Genetic variants [ Time Frame: 10 days postoperative ]
    Percent of subject with genetic variants affecting pain medication

Secondary Outcome Measures :
  1. pain levels [ Time Frame: 10 days postoperatively ]
    0-10 subjective pain scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary total hip or total knee arthroplasty cases

Exclusion Criteria:

  • History of narcotic dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03772535

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United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22307
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
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Principal Investigator: William Hamilton, MD Anderson Orthopaedic Research Institute
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Responsible Party: Anderson Orthopaedic Research Institute Identifier: NCT03772535    
Other Study ID Numbers: AORI 2018-0100
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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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