drugset / Trial / NCT06202989

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

NCT06202989

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-09-09
Primary completion
2026-05-05
Completion
2026-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Amitriptyline Small molecule 2 % Topical
Subject Baclofen Small molecule 5 % Topical
Subject Ketoprofen Small molecule 10 % Topical
Subject Lidocaine Other / unclassified 5 % Topical

Indications

No indication recorded.