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Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

NCT06202989 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Postsurgical Pain

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

Sponsors & Collaborators

Principal Investigators

  • Giuseppe Valente, MD, MMgt, FRCSC · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2026-02-01
Completion
2026-04-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202989 on ClinicalTrials.gov