Knee Arthroplasty, TotalOREOS-KNCT07895472
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
A study testing Multicomponent opioid reduction and pain management pathway in people with Knee Arthroplasty, Total and Partial Knee Arthroplasty, run by McMaster University.
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 Arthroplasty, Total, Partial Knee Arthroplasty, Chronic Pain, Postoperative
- 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
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 knee arthroplasty (total or partial) for knee arthritis
- Provide informed consent to participate
Who cannot join
- Revision surgery
- Simultaneous bilateral arthroplasties
- Inflammatory arthritis (like rheumatoid arthritis)
- Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS): A 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 Arthroplasty, Total, Partial Knee Arthroplasty, Chronic Pain, Postoperative, Osteoarthritis (OA) of the Knee
- Being tested
- Standard care, Multicomponent opioid reduction and pain management pathway
- Keywords
- Total knee arthroplasty, Partial knee arthroplasty, Opioid reduction, Multimodal pain management, Chronic postsurgical pain
- Medical subject headings
- Pain, Postoperative, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Standard perioperative care, surgical treatment, and pain medications.
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.
| 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 |
| Multicomponent pain management | 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: Standard care; 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.
Chronic postsurgical pain
Presence of chronic postsurgical pain (binary) is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded .
Measured: 3 months after surgery
Secondary outcomes (8)
Moderate-to-severe chronic postsurgical pain
Presence of chronic postsurgical pain (binary) is defined as per the definition adopted in International Classification of Diseases version 11; mild-to-moderate is defined as pain intensity of ≥4/10 during ambulation over the last week. Pain intensity will be measured on a numeric rating scale of 0-10 where a lower score is better.
Measured: 3, 6, 9, and 12 months after surgery
Pain control
Time to achieve good pain control (time-to-event); good pain control will be defined as achieving a state of pain intensity of <4/10 during ambulation over the past week without the need for daily opioid medication for the operated knee. Pain intensity will be measured on a numeric rating scale of 0-10 where a lower score is better.
Measured: Up to 3 months after surgery
Chronic postsurgical pain
Presence of chronic postsurgical pain (Binary) is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded.
Measured: 6, 9, and 12 months after surgery
Persistent opioid use
Presence of persistent opioid use (binary), based on patient reporting indicating the need for daily opioid use that started after surgery or increased after surgery .
Measured: 3, 6, 9, and 12 months after surgery
Chronic postsurgical pain intensity
Average intensity of chronic postsurgical pain (continuous) at rest and with movement. Pain intensity will be measured on a numeric rating scale of 0-10 where 0 is better.
Measured: 3, 6, 9, and 12 months after surgery
Satisfaction with pain control
Satisfaction with pain control (continuous) will be measured using a 0 to 100 scale where a higher score is better satisfaction.
Measured: 3, 6, 9, and 12 months after surgery
Knee function
Using the 12-item Oxford Knee Score (continuous) to assess knee function and pain following a total knee replacement. The score range is 0-48 where a higher score is better function.
Measured: 3, 6, 9, and 12 months after surgery
Quality of life
Measured using Euro-Qol 5 dimensions scale consisting of 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This will be transformed to a utility score where 0 is death and 1 is full health (continuous).
Measured: 3, 6, 9, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Harsha Shanthanna, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895472
- Sponsor's protocol ID
- OREOS-K definitive
- Acronym
- OREOS-K
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified trial data
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS): A Randomized Controlled Trial in Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT07895472
- Acronym / sponsor ID
- OREOS-K / OREOS-K definitive
- Conditions
- Knee Arthroplasty, Total, Partial Knee Arthroplasty, Chronic Pain, Postoperative, Osteoarthritis (OA) of the Knee
- Keywords
- Total knee arthroplasty, Partial knee arthroplasty, Opioid reduction, Multimodal pain management, Chronic postsurgical pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 26 Oct 2026 (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
| Arm | Type | Receives |
|---|---|---|
| Standard care group | Active comparator | Other: Standard careThis group will receive standard perioperative care, surgical treatment, and pain medications. |
| Multicomponent pain management | Experimental | Other: Standard care, 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 (3 listed)
- Adult (18+)
- Undergoing elective knee arthroplasty (total or partial) for knee arthritis
- Provide informed consent to participate
Key exclusion criteria (4 listed)
- Revision surgery
- Simultaneous bilateral arthroplasties
- Inflammatory arthritis (like rheumatoid arthritis)
- 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 |
|---|---|---|
| Standard careStandard perioperative care, surgical treatment, and pain medications. | Other | Multicomponent pain management, Standard care group |
| 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 | Multicomponent pain management |
Primary outcome
Chronic postsurgical pain
Time frame: 3 months after surgery
Presence of chronic postsurgical pain (binary) is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded .
8 secondary outcomes
Moderate-to-severe chronic postsurgical pain
Time frame: 3, 6, 9, and 12 months after surgery
Pain control
Time frame: Up to 3 months after surgery
Chronic postsurgical pain
Time frame: 6, 9, and 12 months after surgery
Persistent opioid use
Time frame: 3, 6, 9, and 12 months after surgery
Chronic postsurgical pain intensity
Time frame: 3, 6, 9, and 12 months after surgery
Satisfaction with pain control
Time frame: 3, 6, 9, and 12 months after surgery
Knee function
Time frame: 3, 6, 9, and 12 months after surgery
Quality of life
Time frame: 3, 6, 9, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified trial data
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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.
Harsha Shanthanna, MD, PhD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent opioid reduction and pain management pathway in people with Knee Arthroplasty, Total and Partial Knee Arthroplasty, run by McMaster University.
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 3 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Madden, PhD (905-521-9140, maddenk@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postsurgical pain (time frame: 3 months after surgery). 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 30 Oct 2026.