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

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ClinicalTrials.gov Identifier: NCT04020471
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Tauchen, NorthShore University HealthSystem

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.

Condition or disease
Knee Osteoarthritis Total Knee Arthroplasty (TKA)

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 participatns 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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Variations in Patient Pharmacogenomic Profiles Affect Pain and Narcotic Requirements Following Total Knee Arthroplasty (TKA)
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. Determine how variation in a pharmacogenomics panel affects a patient's perception of pain. [ Time Frame: 30 days ]
    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.

  2. Determine how variation in a pharmacogenomics panel affects the amount of opioids needed to control a patient's pain. [ Time Frame: 30 days ]
    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 equivelants (MME) and expressed as the total MME used in the first post-operative month.


Secondary Outcome Measures :
  1. A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior). [ Time Frame: 1 year ]
    Study subjects will complete the KOOS Jr questionnaire at pre-op, 4 months and 1 year after surgery. KOOS, Jr is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

  2. Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician. [ Time Frame: 1 year ]
    The knee exam/ROM will be completed by the patient's surgeon at standard-of-care clinic visits pre-op, 1 month, 4 months, and 1 year after surgery.

  3. Secondary outcome will be measuring changes in the PROMIS-43. [ Time Frame: 1 year ]
    Subjects will complete the PROMIS-43 questionnaire at pre-op, 4 months and 1 year after surgery. The score comprises questions from seven domains: Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as well as a numeric rating scale for pain from 0-10 with 10 being the worst. They may be reported as T-scores (difference compared to the population average, measure in standard deviations). A score of 50 is the average for the United States general population. For undesirable concepts such as Depression, a T-score of 60 is one standard deviation worse than average. Alternatively, a Depression T-score of 30 is two standard deviations better than average. For favorable concepts like Ability to Participate in Social Roles and Activities, a T-score of 60 is one standard deviation better than average while a T-score of 30 is two standard deviations worse than average.

  4. Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey). [ Time Frame: 1 year ]
    Study subjects will complete the VR-12 at pre-op, 4 months and 1 year after surgery. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The score encompasses questions from seven domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The interval score ranges from 0 to 100 where 0 represents mental or physical disability and 100 represents perfect mental or physical health.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 or older
  • Unilateral primary Total Knee Arthroscopy (TKA)
  • Medical clearance by primary care physician for Total Knee Arthroscopy (TKA)
  • Spinal anesthesia with adductor canal block
  • Knee Osteoarthritis
  • Planned discharge to home
  • Agreement to have a pharmacogenomics profile
  • Body Mass Index (BMI) 35 or below

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
  • Body Mass Index (BMI) 36 or above
  • Previous NorthShore genotyping
  • Currently taking CYP2D6 inhibitors (list in appendix)
  • Currently taking CYP2D6 inducers (list in appendix)

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 ClinicalTrials.gov identifier (NCT number): NCT04020471


Contacts
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Contact: Alexander J Tauchen, MD 847-866-7846 atauchen@northshore.org
Contact: Henry Mark Dunnenberger, PharmD 847-570-3119 mdunnenberger@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Skokie, Illinois, United States, 60076
Contact: Alexander Tauchen, MD    847-866-7846    atauchen@northshore.org   
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Alexander J Tauchen, MD NorthShore University HealthSystem

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Responsible Party: Alexander Tauchen, Physician, FPA, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04020471     History of Changes
Other Study ID Numbers: EH19-023
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Tauchen, NorthShore University HealthSystem:
Pharmacogenomic Profile
Knee Osteoarthritis
Total Knee Arthroplasty (TKA)
Narcotic Use
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents