Pain, JointNCT04585230
A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
A study testing CBD and Mineral Oil in people with Pain, Joint and Pain, Postoperative, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty
- What is being tested?
- CBD and Mineral Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 28 May 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have general anesthesia
- Patients who have documented allergic reactions to ropivacaine in the local infiltration agents
- Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications
- Patients unable to complete a 100-ft walk baseline
- Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery
- Patients undergoing TKA for posttraumatic arthritis
Show all 21Show fewer
- Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis
- Workers compensation patients
- Patients refusing or not candidates for peripheral nerve blocks
- Patients undergoing unicompartmental knee arthroplasty
- Patients undergoing patellofemoral arthroplasty
- Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay
- Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use
- Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period
- Patients who are on chronic narcotics pre-operatively
- Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics
- Patients with adequate cognitive function to participate and complete questionnaires for the study.
- Patients unable or unwilling to follow-up and complete questionnaires for the study
- Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics
- Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS)
- Patients who are determined to be in severe pain from other concomitant conditions
Who cannot join
- patients <18 and >80
- any patient who does not meet the inclusion criteria listed for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects.
In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.
- Conditions
- Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty
- Being tested
- CBD, Mineral Oil, Placebo
- Medical subject headings
- Arthralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
CBD oil Roll-On Stick
Mineral OilDrug
Mineral Oil- Roll on Stick
PlaceboDrug
Roll- On stick with no CBD and no Mineral Oil
| Study group | Role | What they receive |
|---|---|---|
| Group 1: (CBD + MO cohort) | Active comparator | Roll on stick containing CBD and mineral oils (CBD + MO cohort) Receives: Drug: CBD; Drug: Mineral Oil |
| Group 2: (MO cohort) | Active comparator | Roll on stick containing mineral oils only (MO cohort) Receives: Drug: Mineral Oil |
| Group 3: (CBD Cohort) | Active comparator | Roll on stick containing CBD only (CBD cohort) Receives: Drug: CBD |
| Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort) | Placebo comparator | Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
opioid consumption after surgery will be calculated in morphine equivalents
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start12 Oct 2020 (estimated)
- Primary completion28 May 2021 (estimated)
- Study completion28 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, JointStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585230
- Sponsor's protocol ID
- JLON20P.202
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04585230
- Acronym / sponsor ID
- JLON20P.202
- Conditions
- Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 12 Oct 2020 (estimated)
- Primary completion
- 28 May 2021 (estimated)
- Study completion
- 28 May 2021 (estimated)
- First posted
- 14 Oct 2020 (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 arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects.
In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: (CBD + MO cohort) | Active comparator | Drug: CBD, Drug: Mineral OilRoll on stick containing CBD and mineral oils (CBD + MO cohort) |
| Group 2: (MO cohort) | Active comparator | Drug: Mineral OilRoll on stick containing mineral oils only (MO cohort) |
| Group 3: (CBD Cohort) | Active comparator | Drug: CBDRoll on stick containing CBD only (CBD cohort) |
| Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort) | Placebo comparator | Drug: PlaceboRoll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients who have general anesthesia
- Patients who have documented allergic reactions to ropivacaine in the local infiltration agents
- Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications
- Patients unable to complete a 100-ft walk baseline
- Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery
Key exclusion criteria (2 listed)
- patients <18 and >80
- any patient who does not meet the inclusion criteria listed for this study
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 |
|---|---|---|
| CBDCBD oil Roll-On Stick | Drug | Group 1: (CBD + MO cohort), Group 3: (CBD Cohort) |
| Mineral OilMineral Oil- Roll on Stick | Drug | Group 1: (CBD + MO cohort), Group 2: (MO cohort) |
| PlaceboRoll- On stick with no CBD and no Mineral Oil | Drug | Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort) |
Primary outcome
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
Time frame: 14 days
opioid consumption after surgery will be calculated in morphine equivalents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD and Mineral Oil in people with Pain, Joint and Pain, Postoperative, run by Rothman Institute Orthopaedics at 1 site in United States.
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 21 inclusion and 2 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 19 Oct 2020. 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 United States. 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.
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?
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?
Postoperative change in pain and change the need for opiates after total knee arthroplasty. (time frame: 14 days). 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 19 Oct 2020.