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New treatment option for Total Knee Anthroplasty
Official title COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06809998
What this study is testing
What is Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).?
Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL). is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for total knee anthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.