Knee InjuriesTKR ORPNCT05414942
Opioid Reduction Program for Total Knee Replacement Patients
A study testing Opioid Reduction Program in people with Knee Injuries and Knee Injuries and Disorders, run by University of Tennessee at 1 site in United States.
Trial summary
In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries, Knee Injuries and Disorders, Opioid Use
- What is being tested?
- Opioid Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 25 May 2022
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older.
- Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
- Access to a telephone.
- Able to consent in English.
Who cannot join
- Under the age of 18.
- Contraindications to use of opioid medication.
- No access to a telephone.
- Unable to understand consent materials in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.
Read the detailed description
The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.
There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.
- Conditions
- Knee Injuries, Knee Injuries and Disorders, Opioid Use
- Being tested
- Opioid Reduction Program
- Keywords
- Opioid, Total Knee Replacement, Knee Arthroplasty, Knee Injuries, Prevention, Analgesics, Opioid
- Medical subject headings
- Knee Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Reduction ProgramBehavioural
Also called TKR-ORP
Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | No intervention will be administered. |
| Opioid Reduction Program | Experimental | Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery. Receives: Behavioral: Opioid Reduction Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid pills (dose and type) prescribed by Campbell Clinic.
transcribed from medical record at Campbell Clinic
Measured: 12-weeks post-op.
Opioid pills prescribed outside of Campbell Clinic.
assessed via scan of prescription drug monitoring database for Tennessee
Measured: 12-weeks post-op.
Opioid pill count questionnaire.
self-report from participant of how many opioids are left in the bottle at the 12 week assessment
Measured: 12-weeks post-op.
Secondary outcomes (1)
KOOS Jr.
There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme
Measured: 12-weeks post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Aug 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Campbell Clinic
- Responsible party
- Principal investigator, Karen Derefinko, PhD, University of Tennessee
- Investigators
- Karen Derefinko, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414942
- Sponsor's protocol ID
- 21-08206-XP
- Acronym
- TKR ORP
- Status last verified
- Nov 2022
- First submitted
- 1 Jun 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Reduction Program for Total Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT05414942
- Acronym / sponsor ID
- TKR ORP / 21-08206-XP
- Conditions
- Knee Injuries, Knee Injuries and Disorders, Opioid Use
- Keywords
- Opioid, Total Knee Replacement, Knee Arthroplasty, Knee Injuries, Prevention, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Campbell Clinic
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 10 Jun 2022 (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.
In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.
Detailed description
The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.
There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –No intervention will be administered. |
| Opioid Reduction Program | Experimental | Behavioral: Opioid Reduction ProgramParticipants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older.
- Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
- Access to a telephone.
- Able to consent in English.
Key exclusion criteria (4 listed)
- Under the age of 18.
- Contraindications to use of opioid medication.
- No access to a telephone.
- Unable to understand consent materials in English.
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 |
|---|---|---|
| Opioid Reduction ProgramAlso: TKR-ORPSubjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication. | Behavioural | Opioid Reduction Program |
Primary outcome
Opioid pills (dose and type) prescribed by Campbell Clinic.
Time frame: 12-weeks post-op.
transcribed from medical record at Campbell Clinic
Opioid pills prescribed outside of Campbell Clinic.
Time frame: 12-weeks post-op.
assessed via scan of prescription drug monitoring database for Tennessee
Opioid pill count questionnaire.
Time frame: 12-weeks post-op.
self-report from participant of how many opioids are left in the bottle at the 12 week assessment
1 secondary outcome
KOOS Jr.
Time frame: 12-weeks post-op.
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 8 Nov 2022.
- Individual participant dataSharing planned: Yes. It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.
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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.
Karen Derefinko, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Reduction Program in people with Knee Injuries and Knee Injuries and Disorders, run by University of Tennessee 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 4 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 8 Nov 2022. 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?
Opioid pills (dose and type) prescribed by Campbell Clinic. (time frame: 12-weeks post-op.). The study lists 3 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 8 Nov 2022.