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

NCT04585230 | Unknown

• 1 other identifier: JLON20P.202
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Joint; Pain, Postoperative; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative change in pain and change the need for opiates after total knee arthroplasty.

  opioid consumption after surgery will be calculated in morphine equivalents

  14 days

Study Arms (4)

Group 1: (CBD + MO cohort)

ACTIVE COMPARATOR

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

Drug: CBD; Drug: Mineral Oil

Group 2: (MO cohort)

ACTIVE COMPARATOR

Roll on stick containing mineral oils only (MO cohort)

Drug: Mineral Oil

Group 3: (CBD Cohort)

ACTIVE COMPARATOR

Roll on stick containing CBD only (CBD cohort)

Drug: CBD

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CBD DRUG

CBD oil Roll-On Stick

Group 1: (CBD + MO cohort); Group 3: (CBD Cohort)

Mineral Oil DRUG

Mineral Oil- Roll on Stick

Group 1: (CBD + MO cohort); Group 2: (MO cohort)

Placebo DRUG

Roll- On stick with no CBD and no Mineral Oil

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients \<18 and \>80

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Arthralgia; Pain, Postoperative

Interventions

Mineral Oil

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Petrolatum; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: October 12, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)