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A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585230
Recruitment Status : Enrolling by invitation
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Pain, Joint Pain, Postoperative Total Knee Arthroplasty Drug: CBD Drug: Mineral Oil Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Estimated Study Start Date : October 12, 2020
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1: (CBD + MO cohort)
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
 Drug: CBD
CBD oil Roll-On Stick

Drug: Mineral Oil
Mineral Oil- Roll on Stick
Active Comparator: Group 2: (MO cohort)
Roll on stick containing mineral oils only (MO cohort)
 Drug: Mineral Oil
Mineral Oil- Roll on Stick
Active Comparator: Group 3: (CBD Cohort)
Roll on stick containing CBD only (CBD cohort)
 Drug: CBD
CBD oil Roll-On Stick
Placebo Comparator: Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)
Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)
 Drug: Placebo
Roll- On stick with no CBD and no Mineral Oil


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who have general anesthesia
  2. Patients who have documented allergic reactions to ropivacaine in the local infiltration agents
  3. 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
  4. Patients unable to complete a 100-ft walk baseline
  5. Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery
  6. Patients undergoing TKA for posttraumatic arthritis
  7. Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis
  8. Workers compensation patients
  9. Patients refusing or not candidates for peripheral nerve blocks
  10. Patients undergoing unicompartmental knee arthroplasty
  11. Patients undergoing patellofemoral arthroplasty
  12. Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay
  13. Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use
  14. Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period
  15. Patients who are on chronic narcotics pre-operatively
  16. Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics
  17. Patients with adequate cognitive function to participate and complete questionnaires for the study.
  18. Patients unable or unwilling to follow-up and complete questionnaires for the study
  19. Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics
  20. Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS)
  21. Patients who are determined to be in severe pain from other concomitant conditions

Exclusion Criteria:

  1. patients <18 and >80
  2. any patient who does not meet the inclusion criteria listed for this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585230


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04585230    
Other Study ID Numbers: JLON20P.202
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthralgia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Joint Diseases
Musculoskeletal Diseases
Mineral Oil
Emollients
Dermatologic Agents