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

NCT ID: NCT04585230

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2021-05-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: (CBD + MO cohort)

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

Group Type: ACTIVE_COMPARATOR

CBD

Intervention Type: DRUG

CBD oil Roll-On Stick

Mineral Oil

Intervention Type: DRUG

Mineral Oil- Roll on Stick

Group 2: (MO cohort)

Roll on stick containing mineral oils only (MO cohort)

Group Type: ACTIVE_COMPARATOR

Mineral Oil

Intervention Type: DRUG

Mineral Oil- Roll on Stick

Group 3: (CBD Cohort)

Roll on stick containing CBD only (CBD cohort)

Group Type: ACTIVE_COMPARATOR

CBD

Intervention Type: DRUG

CBD oil Roll-On Stick

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Roll- On stick with no CBD and no Mineral Oil

Interventions

CBD

CBD oil Roll-On Stick

Intervention Type: DRUG

Mineral Oil

Mineral Oil- Roll on Stick

Intervention Type: DRUG

Placebo

Roll- On stick with no CBD and no Mineral Oil

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JLON20P.202

Identifier Type: -

Identifier Source: org_study_id