COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
Launched by UNITY HEALTH TORONTO · Jan 30, 2025
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effects of a specific type of treatment called a corticosteroid injection on patients who are undergoing total knee replacement surgery (TKA) due to osteoarthritis, a common joint condition that causes pain and stiffness. The study aims to find out if giving this injection in the knee that is not being operated on can help improve pain and function after surgery. This is a pilot study, meaning it’s an early phase of research to see if this approach is effective.
To participate in this trial, you need to be at least 18 years old and have a diagnosis of primary osteoarthritis requiring a single knee replacement surgery. You should not have had any steroid injections in the other knee in the last year or be planning to have surgery on that knee soon. Participants will be randomly assigned to receive either the corticosteroid injection or a placebo (which looks like the injection but has no active medication), and the study will be conducted in a way that keeps both the participants and researchers unaware of who gets which treatment. If you decide to join, you can expect regular check-ins to assess your pain and how well you're moving after the surgery. This trial is currently recruiting participants, and your involvement could help improve treatment options for others with similar conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients 18 years of age and older
- • Primary osteoarthritis diagnosis with indication for primary elective unilateral TKA
- • No previous contralateral knee injections (steroids/biologics) within one year of study
- • Not scheduled for bilateral TKA or a subsequent staged contralateral TKA within the next six months
- • No previous or active infection or trauma (osseous/ligamentous/extensor mechanism) on the contralateral knee
- • Contralateral knee pain \& symptoms - defined as a VAS of \>4/10 at initial pre-op visit
- • Contralateral knee OA quantified as: Kellgren and Lawrence grade \>2-4
- • Assessed by PI (AK) who will not be contributing any patients to the study through examination of blinded knee radiographs (3 views: AP/lateral/Sunrise)
- • Patient is able to read and understand English and provide informed consent to participation in the study
- Exclusion Criteria:
- • Other aetiologies of OA that warrants TKA (inflammatory or post traumatic arthritis)
- • Cognitive impairment (dementia, Alzheimer's, uncontrolled delirium) which will prevent patients from completing primary outcome measure or comply with follow-up requirements
- • Previous TKA or ORIF or nailing on either knee
- • Previous or active knee infection or extensor mechanism disruption
- • Previous arthroscopy on either knee
- • Medical contraindication to elective TKA surgery
About Unity Health Toronto
Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Patients applied
Trial Officials
Amir Khoshbin, MD, FRCS (C)
Principal Investigator
Unity Health Toronto
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported