Clinical trial NCT04020471: How Variations in Pharmacogenomic Profiles Affect Pain and Narcotic Needs Following Total Knee Arthroplasty (TKA)
Official title: How Variations in Patient Pharmacogenomic Profiles Affect Pain and Narcotic Requirements Following Total Knee Arthroplasty (TKA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty (TKA)
Keywords: Pharmacogenomic Profile
Knee Osteoarthritis
Total Knee Arthroplasty (TKA)
Narcotic Use
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis who are scheduled for a primary total knee replacement and excluding those with significant deformity, partial knee replacement, and revision surgery.

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.

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)

Primary outcomes:
measure: Determine how variation in a pharmacogenomics panel affects a patient's perception of pain.
timeFrame: 30 days
measure: Determine how variation in a pharmacogenomics panel affects the amount of opioids needed to control a patient's pain.
timeFrame: 30 days
Secondary outcomes:
measure: A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior).
timeFrame: 1 year
measure: Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician.
timeFrame: 1 year
measure: Secondary outcome will be measuring changes in the PROMIS-43.
timeFrame: 1 year
measure: Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey).
timeFrame: 1 year
Other outcomes:
Locations:
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Richard L Wixson, MD
role: PRINCIPAL_INVESTIGATOR
References: