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

NCT04020471 | Completed

• 1 other identifier: EH19-023
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty (TKA)

Keywords

Pharmacogenomic Profile; Knee Osteoarthritis; Total Knee Arthroplasty (TKA); Narcotic Use

Outcome Measures

Primary Outcomes (2)

• Determine how variation in a pharmacogenomics panel affects a patient's perception of pain.

  The variation in genetics will be investigated using a standard 20 gene clinical pharmacogenomics panel. Three of these genes (CYP2D6, OPRM1, and COMT) have effects on opioid metabolism, opioid transport, pain perception, and opioid receptors. The results of the pharmacogenomics panel in relation to pain as assessed by the VAS (Visual Analog Scale) numeric pain scale completed by each subject for maximum pain experienced with activity, average pain, and lowest level of pain over the previous 24 hours. The VAS is a self-reported score which measures pain on a 0-10 scale with 10 being the most amount of pain possible and 0 being no pain.

  30 days

• Determine how variation in a pharmacogenomics panel affects the amount of opioids needed to control a patient's pain.

  The results of the pharmacogenomics panel in relation to the amount of opioids needed to control post-operative pain for the first month following surgery will be assessed via a daily medication log completed by patients where they record the specific medication and dose taken in the previous 24 hour period each day of the month following surgery. This will be converted to morphine milligram equivalents (MME) and expressed as the total MME used in the first post-operative month.

  30 days

Secondary Outcomes (4)

• A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior).

  1 year

• Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician.

  1 year

• Secondary outcome will be measuring changes in the PROMIS-43.

  1 year

• Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey).

  1 year

Study Arms (1)

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.

Other: Pain Scale/Medication Log

Interventions

Pain Scale/Medication Log OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Richard L Wixson, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, FPA

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: July 16, 2019
• Study Start: April 11, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)