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Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Postsurgical Pain

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Giuseppe Valente, MD, MMgt, FRCSC

[email protected]
(905) 521-2100
Backup Contact

Kim Madden, PhD

[email protected]
(289) 237-7380
Oakville Trafalgar Memorial Hospital
Oakville Trafalgar Memorial Hospital
Oakville, Ontario
Canada

Contact Study Team

Primary Contact

Heather Brien, MD

905-339-2498
Study Sponsored By
KAZM Pharmaceuticals Inc.
Participants Required
More Information
Study ID: NCT06202989