An interventional study of Opioid Reduction Program in Knee Injuries, Knee Injuries and Disorders and Opioid Use, sponsored by University of Tennessee. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University of Tennessee · Not applicable, Interventional, and Prevention
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 85 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intervention will be administered.
Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery.
Behavioral: Opioid Reduction Program
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.
Also known as: TKR-ORP
Opioid pills (dose and type) prescribed by Campbell Clinic.
transcribed from medical record at Campbell Clinic
Time frame: 12-weeks post-op.
Opioid pills prescribed outside of Campbell Clinic.
assessed via scan of prescription drug monitoring database for Tennessee
Time frame: 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
Time frame: 12-weeks post-op.
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
Time frame: 12-weeks post-op.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Tennessee