Knee OsteoarthritisOREOSNCT04968132
Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees
A study testing Multicomponent opioid reduction and pain management pathway in people with Knee Osteoarthritis and Chronic Post Operative Pain, run by Kim Madden at 1 site in Canada.
Trial summary
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Chronic Post Operative Pain
- What is being tested?
- Multicomponent opioid reduction and pain management pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2022to 14 Jul 2024
- 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
- Adult (18+)
- Undergoing elective total knee arthroplasty (TKA) for knee arthritis
- Can use a simple electronic (phone or tablet) device
- Provide informed consent to participate
Who cannot join
- Revision surgery
- Simultaneous bilateral arthroplasties
- Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.
People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.
This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.
- Conditions
- Knee Osteoarthritis, Chronic Post Operative Pain
- Being tested
- Multicomponent opioid reduction and pain management pathway, Standard care
- Keywords
- Total knee arthroplasty, education, opioid reduction, cognitive behavioural therapy
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent opioid reduction and pain management pathwayOther
Pre-operative pain education and expectation setting, identification and modification of risk factors in high risk patients, postoperative individualized analgesic prescriptions, and continued support for pan control and recovery facilitated by an interventions coordinator.
Standard careOther
Standard perioperative care, surgical treatment, and pain medications.
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | Active comparator | This group will receive standard perioperative care, surgical treatment, and pain medications. Receives: Other: Standard care |
| Opioid reduction group | Experimental | Patients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component. Receives: Other: Multicomponent opioid reduction and pain management pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention adherence [feasibility]
Percentage of patients receiving at least 3 of the 4 trial intervention components.
Measured: 8 weeks
Participant recruitment [feasibility]
Number of participants recruited
Measured: 4 months
Participant retention [feasibility]
Number of participants completing the primary outcome
Measured: 8 weeks
Secondary outcomes (7)
Opioid-free pain control
Three or more consecutive days of <4/10 pain score on a 0-10 numeric rating scale (NRS; lower score is better) with no opioid use for the operated knee.
Measured: 8 weeks
Chronic post-surgical pain (CPSP)
Defined by the International Classification of Diseases version-11 (ICD-11) criteria
Measured: 12 months
CPSP intensity of resting and movement evoked pain
Measured on a 0-10 numeric rating scale (NRS; lower score is better)
Measured: 12 months
Postoperative opioid use
Presence of daily opioid use, started after surgery or increased after surgery (binary)
Measured: 12 months
Satisfaction with pain control
0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)
Measured: 12 months
Health related quality of life
EuroQol-5 Dimensions (EQ-5D)
Measured: 12 months
Complications
Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start9 Mar 2022
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Madden
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, McMaster Surgical Associates, St. Joseph's Healthcare Foundation
- Responsible party
- Sponsor-investigator, Kim Madden, McMaster University
- Investigators
- Harsha Shanthanna, MD PhD FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968132
- Sponsor's protocol ID
- OREOS-knee
- Acronym
- OREOS
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Madden K, Pallapothu S, Young Shing D, Adili A, Bhandari M, Carlesso L, Khan M, Kleinlugtenbelt YV, Krsmanovic A, Nowakowski M, Packham T, Romeril E, Tarride JE, Thabane L, Tushinski DM, Wallace C, Winemaker M, Shanthanna H. Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty. Pilot Feasibility Stud. 2024 Feb 15;10(1):30. doi: 10.1186/s40814-024-01457-9.
PubMed 38360686
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT04968132
- Acronym / sponsor ID
- OREOS / OREOS-knee
- Conditions
- Knee Osteoarthritis, Chronic Post Operative Pain
- Keywords
- Total knee arthroplasty, education, opioid reduction, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kim MaddenUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, McMaster Surgical Associates, St. Joseph's Healthcare Foundation
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 20 Jul 2021 (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.
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.
People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.
This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 group parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard care group | Active comparator | Other: Standard careThis group will receive standard perioperative care, surgical treatment, and pain medications. |
| Opioid reduction group | Experimental | Other: Multicomponent opioid reduction and pain management pathwayPatients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18+)
- Undergoing elective total knee arthroplasty (TKA) for knee arthritis
- Can use a simple electronic (phone or tablet) device
- Provide informed consent to participate
Key exclusion criteria (3 listed)
- Revision surgery
- Simultaneous bilateral arthroplasties
- Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
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 |
|---|---|---|
| Multicomponent opioid reduction and pain management pathwayPre-operative pain education and expectation setting, identification and modification of risk factors in high risk patients, postoperative individualized analgesic prescriptions, and continued support for pan control and recovery facilitated by an interventions coordinator. | Other | Opioid reduction group |
| Standard careStandard perioperative care, surgical treatment, and pain medications. | Other | Standard care group |
Primary outcome
Intervention adherence [feasibility]
Time frame: 8 weeks
Percentage of patients receiving at least 3 of the 4 trial intervention components.
Participant recruitment [feasibility]
Time frame: 4 months
Number of participants recruited
Participant retention [feasibility]
Time frame: 8 weeks
Number of participants completing the primary outcome
7 secondary outcomes
Opioid-free pain control
Time frame: 8 weeks
Chronic post-surgical pain (CPSP)
Time frame: 12 months
CPSP intensity of resting and movement evoked pain
Time frame: 12 months
Postoperative opioid use
Time frame: 12 months
Satisfaction with pain control
Time frame: 12 months
Health related quality of life
Time frame: 12 months
Complications
Time frame: 12 months
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 3 Dec 2024.
- Background: PubMed 38360686Madden K, Pallapothu S, Young Shing D, Adili A, Bhandari M, Carlesso L, Khan M, Kleinlugtenbelt YV, Krsmanovic A, Nowakowski M, Packham T, Romeril E, Tarride JE, Thabane L, Tushinski DM, Wallace C, Winemaker M, Shanthanna H. Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty. Pilot Feasibility Stud. 2024 Feb 15;10(1):30. doi: 10.1186/s40814-024-01457-9.
- 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.
Harsha Shanthanna, MD PhD FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent opioid reduction and pain management pathway in people with Knee Osteoarthritis and Chronic Post Operative Pain, run by Kim Madden at 1 site in Canada.
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 3 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 3 Dec 2024. 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 Canada. 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?
Intervention adherence [feasibility] (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT04968132, which also lists 1 linked publication.
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 3 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.