Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: a Blinded Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (18+)

• Undergoing Primary Elective TKA

• Provide informed consent

Locations
Other Locations
Canada
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Oakville Trafalgar Memorial Hospital
NOT_YET_RECRUITING
Oakville
Contact Information
Primary
Kim Madden, PhD
maddenk@mcmaster.ca
289-237-7380
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 288
Treatments
Experimental: Multiprofen-CC™
Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery
Placebo_comparator: Control
Standard care pain medications and visually identical topical placebo (1g TID) for 6 weeks after surgery
Sponsors
Collaborators: McMaster University
Leads: KAZM Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov