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RECRUITING
NCT06202989
PHASE3

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Sponsor: KAZM Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

OTHER

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