Status:
RECRUITING
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Lead Sponsor:
KAZM Pharmaceuticals Inc.
Collaborating Sponsors:
McMaster University
Conditions:
Postsurgical Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tota...
Detailed Description
Total knee replacement, also known as total knee arthroplasty (TKA), is a surgical procedure aimed at alleviating pain and improving joint function in individuals with severe knee joint damage, often ...
Eligibility Criteria
Inclusion
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
Exclusion
- Administration of any investigational drug in the period of 0 to 45 days before entry into the study
- Pregnancy
- Actively breastfeeding
- Unable to provide informed consent (e.g. cognitive disability)
- Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical treatments as instructed)
- Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or lidocaine, any of the study drugs or their ingredients
- Have a history of substance abuse
- Use daily opioids (other than short acting codeine) for a chronic pain condition other than knee OA
- Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
- Diagnosis of uncontrolled hypertension
- Diagnosis of active peptic ulcer disease
- A history of chronic (\> 3 months) anticoagulant usage
- History of impaired kidney or liver function
- Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision
- Body Mass Index (BMI) \> 50kg/m2
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06202989
Start Date
September 9 2024
End Date
April 1 2026
Last Update
December 10 2025
Active Locations (2)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
2
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada, L6M 0L8