COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
Recruiting · NCT06809998 · Interventional (participants receive a specific treatment) · Lead sponsor: Unity Health Toronto
View the official record on ClinicalTrials.gov →Interventions studied
Band-AidCorticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- St. Michael's Hospital - Toronto, Ontario, Canada