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

Primary Purpose

Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBD
Mineral Oil
Placebo
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Joint

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1: (CBD + MO cohort)

Group 2: (MO cohort)

Group 3: (CBD Cohort)

Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)

Arm Description

Roll on stick containing CBD and mineral oils (CBD + MO cohort)

Roll on stick containing mineral oils only (MO cohort)

Roll on stick containing CBD only (CBD cohort)

Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)

Outcomes

Primary Outcome Measures

Postoperative change in pain and change the need for opiates after total knee arthroplasty.
opioid consumption after surgery will be calculated in morphine equivalents

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
October 16, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04585230
Brief Title
A Study to Evaluate 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Anticipated)
Primary Completion Date
May 28, 2021 (Anticipated)
Study Completion Date
May 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: (CBD + MO cohort)
Arm Type
Active Comparator
Arm Description
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
Arm Title
Group 2: (MO cohort)
Arm Type
Active Comparator
Arm Description
Roll on stick containing mineral oils only (MO cohort)
Arm Title
Group 3: (CBD Cohort)
Arm Type
Active Comparator
Arm Description
Roll on stick containing CBD only (CBD cohort)
Arm Title
Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)
Arm Type
Placebo Comparator
Arm Description
Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
CBD oil Roll-On Stick
Intervention Type
Drug
Intervention Name(s)
Mineral Oil
Intervention Description
Mineral Oil- Roll on Stick
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Roll- On stick with no CBD and no Mineral Oil
Primary Outcome Measure Information:
Title
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
Description
opioid consumption after surgery will be calculated in morphine equivalents
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: patients <18 and >80 any patient who does not meet the inclusion criteria listed for this study
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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