Corticosteroid injection for knee surgery patients
COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study
This study is testing if giving corticosteroid injections to the other knee can help people with both knees affected by osteoarthritis recover better after knee surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06809998 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of administering corticosteroid injections to the contralateral knee in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. It is a triple-blinded randomized control trial aimed at assessing pain relief and functional outcomes post-surgery. The study focuses on patients with bilateral knee osteoarthritis, where the contralateral knee may also experience pain and limited function. By using corticosteroids, the study seeks to improve rehabilitation outcomes and reduce postoperative stiffness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary osteoarthritis requiring unilateral TKA and significant pain in the contralateral knee.
Not a fit: Patients with other causes of osteoarthritis or those scheduled for bilateral TKA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and quality of life for patients undergoing knee surgery by alleviating pain and improving function in both knees.
How similar studies have performed: Previous studies have shown moderate success with corticosteroid injections in managing pain and improving function in arthritic joints, suggesting potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amir Khoshbin, MD, FRCS (C) — Unity Health Toronto
- Study coordinator: Cassandra Tardif-Theriault, BKin
- Email: cassandra.tardif-theriault@unityhealth.to
- Phone: 416-864-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.