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History of Changes for Study: NCT04585230
Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Latest version (submitted October 16, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2020 None (earliest Version on record)
2 October 16, 2020 Recruitment Status, Study Status, Outcome Measures and Study Identification
Comparison Format:

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Study NCT04585230
Submitted Date:  October 12, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: JLON20P.202
Brief Title: Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Official Title: Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Enrolling by invitation
Study Start: October 12, 2020
Primary Completion: May 28, 2021 [Anticipated]
Study Completion: May 28, 2021 [Anticipated]
First Submitted: October 6, 2020
First Submitted that
Met QC Criteria:
October 12, 2020
First Posted: October 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 12, 2020
Last Update Posted: October 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pain, Joint
Pain, Postoperative
Total Knee Arthroplasty
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 92 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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