How Variations in Pharmacogenomic Profiles Affect Pain and Narcotic Needs Following Total Knee Arthroplasty (TKA)

NCT ID: NCT04020471

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 375 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement.

Detailed Description

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement. People experience pain differently. The type and amount of medication required to control pain varies. Post-operative pain often requires narcotics to keep patients comfortable. It has been shown that there is a genetic difference in how people respond to pain and how they respond to the medications used for the relief of pain. Opioids are often used to relieve pain after surgery. These medications can be abused and have had a role in the current opioid crisis.

Pharmacogenomics is the study of how patients respond to and metabolize drugs and medications based on their genetic profiles. This study will collect data on the pain experienced by participants and the narcotics used after total knee replacements. This will be correlated with the participants' pharmacogenomic profiles obtained though DNA testing. There are no treatment interventions in this study. Although a pharmacogenomic profile will be obtained at the first post-operative visit and reported approximately 3 weeks later, the subject will have completed the need for pain relief. The study is expected to last 2 years with 300 subjects enrolled.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty (TKA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental

All subjects who have completed their standard of care total knee arthroplasty will undergo pharmacogenomics testing and will complete a daily pain and medication diary for 30 days post discharge from the hospital. Subjects will be offered a consultation visit with a member of the Pharmacogenomics Team to discuss results.

Pain Scale/Medication Log

Intervention Type: OTHER

Daily recording of pain level after surgery and recording of medication taken for pain relief.

Interventions

Pain Scale/Medication Log

Daily recording of pain level after surgery and recording of medication taken for pain relief.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Unilateral primary Total Knee Arthroscopy (TKA)
• Knee Osteoarthritis
• Planned discharge to home

Exclusion Criteria

• Unicompartmental Total Knee Arthroscopy (TKA)
• Revision Total Knee Arthroscopy (TKA)
• Knee flexion contracture > 15°
• Axial deformity > 15°
• Previous or current chronic narcotic use for pain > 3 months
• Previous or current substance abuse
• Any chronic pain condition
• Any dementia or cognitive disorder
• Discharge to Skilled Nursing Facility
• Rheumatoid arthritis
• Potential difficulty completing daily pain scores and medication use
• Previous NorthShore genotyping
• Currently taking CYP2D6 inhibitors (list in appendix)
• Currently taking CYP2D6 inducers (list in appendix)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Richard Wixson

Physician, FPA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard L Wixson, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem

Skokie, Illinois, United States

Countries

United States

Other Identifiers

EH19-023

Identifier Type: -

Identifier Source: org_study_id