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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 : Unknown
Verified October 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 19, 2020
Estimated Study Start Date  ICMJE October 12, 2020
Estimated Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
Postoperative pain reduction and reduce the need for opiates after total knee arthroplasty. [ Time Frame: 14 days ]
opioid consumption after surgery will be calculated in morphine equivalents
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Official Title  ICMJE Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Joint
  • Pain, Postoperative
  • Total Knee Arthroplasty
Intervention  ICMJE
  • Drug: CBD
    CBD oil Roll-On Stick
  • Drug: Mineral Oil
    Mineral Oil- Roll on Stick
  • Drug: Placebo
    Roll- On stick with no CBD and no Mineral Oil
Study Arms  ICMJE
  • Active Comparator: Group 1: (CBD + MO cohort)
    Roll on stick containing CBD and mineral oils (CBD + MO cohort)
    Interventions:
    • Drug: CBD
    • Drug: Mineral Oil
  • Active Comparator: Group 2: (MO cohort)
    Roll on stick containing mineral oils only (MO cohort)
    Intervention: Drug: Mineral Oil
  • Active Comparator: Group 3: (CBD Cohort)
    Roll on stick containing CBD only (CBD cohort)
    Intervention: Drug: CBD
  • 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)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 12, 2020)
92
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 28, 2021
Estimated Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04585230
Other Study ID Numbers  ICMJE JLON20P.202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP