Arthroplasty, Replacement, KneePhase 2/3COPENCT03675971
COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
A Phase 2/3 study testing Cannabinol in people with Arthroplasty, Replacement, Knee, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Cannabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2020to May 2022
- Phase
- Phase 2/3
- 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 of age and older
- Men and women
- Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement
- Patients undergoing primary unilateral total knee replacement
- Patient is able to provide informed consent to participation in the study
Who cannot join
- Pregnancy
- Breastfeeding
- Current opioid use
- Cognitive impairment or mental illness (e.g., dementia, Alzheimer disease and psychoses), which will prevent patients from reliably providing primary outcome data
- Unable to swallow an oral tablet (medication)
- History of opiate, narcotic and alcohol abuse
Show all 10Show fewer
- Revision total knee replacement surgery
- High risk of falls as determined by the treating physician
- Patients refusing participation
- Pre-existing/ regular cannabis use
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Luana Melo, PhD
Amit Atrey, MD
About this study
Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery.
Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction.
Read more
Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief.
This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.
Read the detailed description
COPE (Cannabinoids to Obviate Pain Experiment after knee replacement) will be a single-centre, prospective, randomized, placebo-controlled, superiority trial, with two parallel groups designed to investigate the effect of cannabis as postoperative pain treatment compared to placebo on total opioid consumption after total knee replacement.
Eligible patients are: men and non-pregnant women aged ≥18 years scheduled to undergo primary total knee replacement. and with no opioid usage within the last 3 months or history of narcotic abuse.
Patients will be recruited at the department of orthopaedic surgery at St Michael's Hospital (Toronto - Canada), and informed consent will be obtained from those eligible. Central computer-generated randomization will be used to randomly assign participants to cannabis or placebo groups (1:1 ratio). Only the study pharmacist will know allocated treatments.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Cannabinol, Placebo oral capsule
- Keywords
- Pain Management; Analgesics, Opioid; Cannabis
- Medical subject headings
- Agnosia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabinolDrug
Also called medical cannabis
Postoperative pain treatment
Placebo oral capsuleDrug
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Medical Cannabis | Experimental | Drug: Cannabidiol Receives: Drug: Cannabinol |
| Placebo | Placebo comparator | Placebo comparator Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Assess cumulative opioid consumption (morphine equivalent dose) by means of drug reconciliation (medication diaries and pill counts) i.e. patients will self report how many opioid pills they took each day, by means of the medication diaries and at 4 weeks follow up will bring the pills back to clinic appointment.
Measured: 2 weeks after total knee replacement
Secondary outcomes (6)
Visual Analog Pain Scale
Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
Measured: Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement
Oxford knee score
A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after knee replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
Measured: Questionnaire will be completed by patients at 6 weeks after knee replacement
Health status and quality of life
EQ-5D is a questionnaire where patients self-rate their level of severity of health status and health-related quality of life. Consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Measured: Questionnaire will be completed by patients at 6 weeks after knee replacement
Quality of recovery - 15 (QoR-15)
Quality of recovery scores are patient-reported outcome measures evaluating recovery after surgery regarding the last 24h. It is a short-form score with 15 questions that assess the 5 dimensions (pain, physical comfort, physical independence, physiological support and emotional state) and has 2 parts (A and B). Part A scores from 0 [poor] to 10 [excellent] - as higher is the score as better is the recovery. Part B scores from 10 [excellent] to 0 [poor] - as higher is the score as better is the recovery.
Measured: Questionnaire will be completed by patients at 12 weeks after knee replacement
Self-reported opioid use and urinalysis
Patients will self report whether they are still using opioids (yes or no) and they will undergo a urinalysis (urine test). Patients will pee in a designed cup and a trained assessed will test the urine (with chemical strip) to detect the presence of one or more opioids in urine.
Measured: The test will be completed at 12 weeks after knee replacement
Narcotic monitoring prescription
Using data from the Narcotics Monitoring System from ICES (Institute for Clinical Evaluative Sciences) which already captures all opioid prescriptions dispensed in retail pharmacies across Ontario, the investigators will assess if participants have had any filled prescription after knee replacement and record the number of prescriptions filled.
Measured: Will be assessed at 12 months after knee replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 May 2020 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Atrey, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675971
- Sponsor's protocol ID
- RCT19-366965
- Acronym
- COPE
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2016-2017: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2018
Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.
PubMed 28288050Canata GL, Casale V, Chiey A. Pain management in total knee arthroplasty: efficacy of a multimodal opiate-free protocol. Joints. 2017 Feb 7;4(4):222-227. doi: 10.11138/jts/2016.4.4.222. eCollection 2016 Oct-Dec.
PubMed 28217658Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.
PubMed 30063596Hadlandsmyth K, Vander Weg MW, McCoy KD, Mosher HJ, Vaughan-Sarrazin MS, Lund BC. Risk for Prolonged Opioid Use Following Total Knee Arthroplasty in Veterans. J Arthroplasty. 2018 Jan;33(1):119-123. doi: 10.1016/j.arth.2017.08.022. Epub 2017 Aug 24.
PubMed 28927564Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
PubMed 25911660Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
PubMed 26871536Franklin PD, Karbassi JA, Li W, Yang W, Ayers DC. Reduction in narcotic use after primary total knee arthroplasty and association with patient pain relief and satisfaction. J Arthroplasty. 2010 Sep;25(6 Suppl):12-6. doi: 10.1016/j.arth.2010.05.003. Epub 2010 Jun 26.
PubMed 20580191Soffin EM, Waldman SA, Stack RJ, Liguori GA. An Evidence-Based Approach to the Prescription Opioid Epidemic in Orthopedic Surgery. Anesth Analg. 2017 Nov;125(5):1704-1713. doi: 10.1213/ANE.0000000000002433.
PubMed 29049115Cozowicz C, Olson A, Poeran J, Morwald EE, Zubizarreta N, Girardi FP, Hughes AP, Mazumdar M, Memtsoudis SG. Opioid prescription levels and postoperative outcomes in orthopedic surgery. Pain. 2017 Dec;158(12):2422-2430. doi: 10.1097/j.pain.0000000000001047.
PubMed 28891865Lynch ME, Campbell F. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
PubMed 21426373Schrot RJ, Hubbard JR. Cannabinoids: Medical implications. Ann Med. 2016;48(3):128-41. doi: 10.3109/07853890.2016.1145794. Epub 2016 Feb 25.
PubMed 26912385Manzanares J, Julian M, Carrascosa A. Role of the cannabinoid system in pain control and therapeutic implications for the management of acute and chronic pain episodes. Curr Neuropharmacol. 2006 Jul;4(3):239-57. doi: 10.2174/157015906778019527.
PubMed 18615144Vigil JM, Stith SS, Adams IM, Reeve AP. Associations between medical cannabis and prescription opioid use in chronic pain patients: A preliminary cohort study. PLoS One. 2017 Nov 16;12(11):e0187795. doi: 10.1371/journal.pone.0187795. eCollection 2017.
PubMed 29145417Lucas P, Walsh Z. Medical cannabis access, use, and substitution for prescription opioids and other substances: A survey of authorized medical cannabis patients. Int J Drug Policy. 2017 Apr;42:30-35. doi: 10.1016/j.drugpo.2017.01.011. Epub 2017 Feb 9.
PubMed 28189912
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
- ClinicalTrials.gov ID
- NCT03675971
- Acronym / sponsor ID
- COPE / RCT19-366965
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Pain Management; Analgesics, Opioid; Cannabis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 18 Sep 2018 (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.
Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery.
Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction.
Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief.
This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.
Detailed description
COPE (Cannabinoids to Obviate Pain Experiment after knee replacement) will be a single-centre, prospective, randomized, placebo-controlled, superiority trial, with two parallel groups designed to investigate the effect of cannabis as postoperative pain treatment compared to placebo on total opioid consumption after total knee replacement.
Eligible patients are: men and non-pregnant women aged ≥18 years scheduled to undergo primary total knee replacement. and with no opioid usage within the last 3 months or history of narcotic abuse.
Patients will be recruited at the department of orthopaedic surgery at St Michael's Hospital (Toronto - Canada), and informed consent will be obtained from those eligible. Central computer-generated randomization will be used to randomly assign participants to cannabis or placebo groups (1:1 ratio). Only the study pharmacist will know allocated treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Medical Cannabis | Experimental | Drug: CannabinolDrug: Cannabidiol |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Men and women
- Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement
- Patients undergoing primary unilateral total knee replacement
- Patient is able to provide informed consent to participation in the study
Key exclusion criteria (10 listed)
- Pregnancy
- Breastfeeding
- Current opioid use
- Cognitive impairment or mental illness (e.g., dementia, Alzheimer disease and psychoses), which will prevent patients from reliably providing primary outcome data
- Unable to swallow an oral tablet (medication)
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 |
|---|---|---|
| CannabinolAlso: medical cannabisPostoperative pain treatment | Drug | Medical Cannabis |
| Placebo oral capsuleAlso: PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Opioid consumption
Time frame: 2 weeks after total knee replacement
Assess cumulative opioid consumption (morphine equivalent dose) by means of drug reconciliation (medication diaries and pill counts) i.e. patients will self report how many opioid pills they took each day, by means of the medication diaries and at 4 weeks follow up will bring the pills back to clinic appointment.
6 secondary outcomes
Visual Analog Pain Scale
Time frame: Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement
Oxford knee score
Time frame: Questionnaire will be completed by patients at 6 weeks after knee replacement
Health status and quality of life
Time frame: Questionnaire will be completed by patients at 6 weeks after knee replacement
Quality of recovery - 15 (QoR-15)
Time frame: Questionnaire will be completed by patients at 12 weeks after knee replacement
Self-reported opioid use and urinalysis
Time frame: The test will be completed at 12 weeks after knee replacement
Narcotic monitoring prescription
Time frame: Will be assessed at 12 months after knee replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- BackgroundCanadian Institute for Health Information. Hip and Knee Replacements in Canada, 2016-2017: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2018
- Background: PubMed 28288050Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.
- Background: PubMed 28217658Canata GL, Casale V, Chiey A. Pain management in total knee arthroplasty: efficacy of a multimodal opiate-free protocol. Joints. 2017 Feb 7;4(4):222-227. doi: 10.11138/jts/2016.4.4.222. eCollection 2016 Oct-Dec.
- Background: PubMed 30063596Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.
- Background: PubMed 28927564Hadlandsmyth K, Vander Weg MW, McCoy KD, Mosher HJ, Vaughan-Sarrazin MS, Lund BC. Risk for Prolonged Opioid Use Following Total Knee Arthroplasty in Veterans. J Arthroplasty. 2018 Jan;33(1):119-123. doi: 10.1016/j.arth.2017.08.022. Epub 2017 Aug 24.
- Background: PubMed 25911660Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
- Background: PubMed 26871536Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
- Background: PubMed 20580191Franklin PD, Karbassi JA, Li W, Yang W, Ayers DC. Reduction in narcotic use after primary total knee arthroplasty and association with patient pain relief and satisfaction. J Arthroplasty. 2010 Sep;25(6 Suppl):12-6. doi: 10.1016/j.arth.2010.05.003. Epub 2010 Jun 26.
- Background: PubMed 29049115Soffin EM, Waldman SA, Stack RJ, Liguori GA. An Evidence-Based Approach to the Prescription Opioid Epidemic in Orthopedic Surgery. Anesth Analg. 2017 Nov;125(5):1704-1713. doi: 10.1213/ANE.0000000000002433.
- Background: PubMed 28891865Cozowicz C, Olson A, Poeran J, Morwald EE, Zubizarreta N, Girardi FP, Hughes AP, Mazumdar M, Memtsoudis SG. Opioid prescription levels and postoperative outcomes in orthopedic surgery. Pain. 2017 Dec;158(12):2422-2430. doi: 10.1097/j.pain.0000000000001047.
- Background: PubMed 21426373Lynch ME, Campbell F. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
- Background: PubMed 26912385Schrot RJ, Hubbard JR. Cannabinoids: Medical implications. Ann Med. 2016;48(3):128-41. doi: 10.3109/07853890.2016.1145794. Epub 2016 Feb 25.
- Individual participant dataSharing planned: No
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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.
Amit Atrey, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabinol in people with Arthroplasty, Replacement, Knee, run by Unity Health Toronto 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luana Melo, PhD (416-864-6060 ext. 77286, melol@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 2 weeks after total knee replacement). 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 NCT03675971, which also lists 15 linked publications.
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 1 Oct 2019.