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Opioid Reduction Strategy for Postoperative Knee Pain (OREOS Trial)

N/A
Waitlist Available
Led By Harsha Shanthanna, MD PhD FRCPC
Research Sponsored by Kim Madden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing elective total knee arthroplasty (TKA) for knee arthritis
Adult (18+)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

OREOS Trial Summary

This trial will help improve pain control and decrease opioid use after knee replacements, which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids.

Who is the study for?
This trial is for adults over 18 who are having knee replacement surgery due to arthritis and can use a phone or tablet. It's not for those needing revision surgery, with cognitive disabilities or language barriers without support, or getting both knees replaced at once.Check my eligibility
What is being tested?
The study compares usual care after knee surgery with a new program aiming to better manage pain and reduce opioid use. The program includes education, physiotherapy, psychological therapy, cold treatments, and non-opioid meds, monitored by an intervention coordinator.See study design
What are the potential side effects?
While the side effects aren't detailed here, potential ones may include discomfort from non-opioid pain medications or therapies used in the new pathway compared to standard opioid-based treatment.

OREOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for knee replacement surgery due to arthritis.
Select...
I am 18 years old or older.

OREOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention adherence [feasibility]
Participant recruitment [feasibility]
Participant retention [feasibility]
Secondary outcome measures
CPSP intensity of resting and movement evoked pain
Chronic post-surgical pain (CPSP)
Complications
+4 more
Other outcome measures
Health economics

OREOS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid reduction groupExperimental Treatment1 Intervention
Patients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component.
Group II: Standard care groupActive Control1 Intervention
This group will receive standard perioperative care, surgical treatment, and pain medications.

Find a Location

Who is running the clinical trial?

Kim MaddenLead Sponsor
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,444 Total Patients Enrolled
1 Trials studying Osteoarthritis
64 Patients Enrolled for Osteoarthritis
McMaster Surgical AssociatesOTHER
16 Previous Clinical Trials
46,419 Total Patients Enrolled

Media Library

Multicomponent opioid reduction and pain management pathway Clinical Trial Eligibility Overview. Trial Name: NCT04968132 — N/A
Osteoarthritis Research Study Groups: Opioid reduction group, Standard care group
Osteoarthritis Clinical Trial 2023: Multicomponent opioid reduction and pain management pathway Highlights & Side Effects. Trial Name: NCT04968132 — N/A
Multicomponent opioid reduction and pain management pathway 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968132 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being monitored for the clinical research?

"Affirmative, clinicaltrials.gov provides evidence that this medical trial is recruiting subjects. It was initially posted on March 9th 2022 and recently updated on April 4th 2022. There are 100 spots open across a single site participating in the study."

Answered by AI

Are there still opportunities for participation in this research protocol?

"Indeed, information available on clinicaltrials.gov indicates that this research endeavour is actively accepting participants. The trial was initially posted on March 9th 2022 and has recently been updated on April 4th 2022, wherein it seeks 100 individuals across a single site for the study."

Answered by AI

What are the chief aims of this clinical experiment?

"The primary endpoint evaluated over an 8 week period is the recruitment feasibility. Secondary objectives encompass postoperative opioid use (daily usage initiated or increased after surgery; binary), opioid-free pain control (three days of <4/10 NRS with no opioids for operated knee) and CPSP intensity of resting and movement evoked pain (NRS rating 0-10)."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees
Kim Madden 2022. "Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968132.
~0 spots leftby May 2024
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