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Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Sponsor: KAZM Pharmaceuticals Inc.
Summary
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.
Official title: Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2024-09-09
Completion Date
2026-04-01
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Multiprofen-CC™ plus standard treatment
Multiprofen-CC™ \[ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)\] Dose: 1.0g, 3 times per day for 6 weeks after surgery
Placebo plus standard treatment
The placebo is the base cream with no medicinal ingredients to be applied 3 times per day for 6 weeks after surgery
Locations (2)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada