Actively Recruiting
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Led by KAZM Pharmaceuticals Inc. · Updated on 2025-12-10
288
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
Sponsors
K
KAZM Pharmaceuticals Inc.
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty. Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.
CONDITIONS
Official Title
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
You will not qualify if you...
- Administration of any investigational drug in the period of 0 to 45 days before entry into the study
- Pregnancy
- Actively breastfeeding
- Unable to provide informed consent (e.g. cognitive disability)
- Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical treatments as instructed)
- Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or lidocaine, any of the study drugs or their ingredients
- Have a history of substance abuse
- Use daily opioids (other than short acting codeine) for a chronic pain condition other than knee OA
- Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
- Diagnosis of uncontrolled hypertension
- Diagnosis of active peptic ulcer disease
- A history of chronic (> 3 months) anticoagulant usage
- History of impaired kidney or liver function
- Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision
- Body Mass Index (BMI) > 50kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
2
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada, L6M 0L8
Not Yet Recruiting
Research Team
B
Breanne Flood, MSc
CONTACT
K
Kim Irish, BSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here