NCT03772535

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

December 3, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

December 10, 2018

Last Update Submit

February 10, 2021

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

  • Genetic variants

    Percent of subject with genetic variants affecting pain medication

    10 days postoperative

Secondary Outcomes (1)

  • pain levels

    10 days postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

Subjects in this arm will receive the standard postoperative pain prescription protocol.

Pharmacogenomics Guided Group

ACTIVE COMPARATOR

Subjects in this group will receive postoperative pain prescriptions based on the results of pharmacogenomic testing.

Diagnostic Test: Pharmacogenomics Testing

Interventions

Pharmacogenomics TestingDIAGNOSTIC_TEST

The doctor will use genetic test results to prescribe medications that are a most effective for subject.

Pharmacogenomics Guided Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip or total knee arthroplasty cases

You may not qualify if:

  • History of narcotic dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22307, United States

Location

Study Officials

  • William Hamilton, MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 11, 2018

Study Start

December 3, 2018

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations

US(1)