Knee OsteoarthritisNCT04020471
How Variations in Pharmacogenomic Profiles Affect Pain and Narcotic Needs Following Total Knee Arthroplasty (TKA)
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty (TKA), run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty (TKA)
- What is being tested?
- Pain Scale/Medication Log
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 or older
- Unilateral primary Total Knee Arthroscopy (TKA)
- Knee Osteoarthritis
- Planned discharge to home
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Skokie, Illinois, 60076
About this study
Official title: How Variations in Patient Pharmacogenomic Profiles Affect Pain and Narcotic Requirements Following Total Knee Arthroplasty (TKA)
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.
Read the 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)
- Being tested
- Pain Scale/Medication Log
- Keywords
- Pharmacogenomic Profile, Knee Osteoarthritis, Total Knee Arthroplasty (TKA), Narcotic Use
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Scale/Medication LogOther
Daily recording of pain level after surgery and recording of medication taken for pain relief.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pain Scale/Medication Log |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (4)
A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior).
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.
Measured: 1 year
Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician.
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.
Measured: 1 year
Secondary outcome will be measuring changes in the PROMIS-43.
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.
Measured: 1 year
Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey).
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start11 Apr 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Wixson, Endeavor Health
- Investigators
- Richard L Wixson, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020471
- Sponsor's protocol ID
- EH19-023
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Variations in Patient Pharmacogenomic Profiles Affect Pain and Narcotic Requirements Following Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT04020471
- Acronym / sponsor ID
- EH19-023
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty (TKA)
- Keywords
- Pharmacogenomic Profile, Knee Osteoarthritis, Total Knee Arthroplasty (TKA), Narcotic Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Pain Scale/Medication LogAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age 18 or older
- Unilateral primary Total Knee Arthroscopy (TKA)
- Knee Osteoarthritis
- Planned discharge to home
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Scale/Medication LogDaily recording of pain level after surgery and recording of medication taken for pain relief. | Other | Experimental |
Primary outcome
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.
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 equivalents (MME) and expressed as the total MME used in the first post-operative month.
4 secondary outcomes
A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior).
Time frame: 1 year
Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician.
Time frame: 1 year
Secondary outcome will be measuring changes in the PROMIS-43.
Time frame: 1 year
Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Wixson, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty (TKA), run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine how variation in a pharmacogenomics panel affects a patient's perception of pain. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.