
1 minute read
Seed Grants - Topicals for Osteoarthritis Pain in Knee Surgery (TOPIKS): A Pilot Randomized Controlled Trial
Topicals for Osteoarthritis Pain in Knee Surgery (TOPIKS): A Pilot Randomized Controlled Trial
Primary Investigator: Harsha Shanthanna, MD, PhD, FRCPC
Start Date: 2019
Brief Overview and Progress to Date
The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of topical cannabidiol (CBD) and/or topical diclofenac versus placebo on postoperative pain and opioid use in patients after primary total knee arthroplasty.
This will be a 2x2 factorial trial assessing the following treatments: Topical diclofenac, Topical CBD, Topical diclofenac and topical CBD, and Placebo. The conduct of this trial requires No Objection Letter (NOL) from Health Canada for the use of CBD product. We have been in discussion with several medical Cannabis suppliers to support this trial to provide us with topical CBD product that is manufactured as per GMP compliant practices and preclinical data.
After multiple discussions, we are now working with a company that is interested in providing support and working towards getting safety data to facilitate Health Canada application.