COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty (NCT06809998) | Clinical Trial Compass
RecruitingPhase 1/2
COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
Canada60 participantsStarted 2025-01-24
Plain-language summary
Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.
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:
* 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
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.
What they're measuring
1
Oxford Knee Score (OKS)
Timeframe: 4-, 8-, 12-weeks and 1-year post-surgery