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

Sponsor
Rothman Institute Orthopaedics (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04585230
Collaborator
(none)
92
1
4
7.5
12.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Oct 12, 2020
Anticipated Primary Completion Date :
May 28, 2021
Anticipated Study Completion Date :
May 28, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Postoperative change in pain and change the need for opiates after total knee arthroplasty. [14 days]

    opioid consumption after surgery will be calculated in morphine equivalents

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Rothman Orthopaedic Institute Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT04585230
Other Study ID Numbers:
  • JLON20P.202
First Posted:
Oct 14, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
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:

Study Results

No Results Posted as of Oct 19, 2020