NCT06809998 COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
| NCT ID | NCT06809998 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Unity Health Toronto |
| Condition | Total Knee Anthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-24 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-01-24 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Amir Khoshbin, MD, FRCS (C)
PRINCIPAL INVESTIGATOR
Unity Health Toronto
Frequently Asked Questions
Who can join the NCT06809998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Anthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06809998 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06809998 currently recruiting?
Yes, NCT06809998 is actively recruiting participants. Contact the research team at cassandra.tardif-theriault@unityhealth.to for enrollment information.
Where is the NCT06809998 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06809998 clinical trial?
NCT06809998 is sponsored by Unity Health Toronto. The principal investigator is Amir Khoshbin, MD, FRCS (C) at Unity Health Toronto. The trial plans to enroll 60 participants.