Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty (NCT06202989) | Clinical Trial Compass
CompletedPhase 3
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Canada306 participantsStarted 2024-09-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (18+)
* Undergoing Primary Elective TKA
* Provide informed consent
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.