Total Knee Anthroplasty study: Corticosteroid Injection - vs Band-Aid
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
- The study wants to see if giving a corticosteroid injection to the other knee around the time of surgery helps. It also looks at whether the injection changes pain and how well patients function after surgery.
- Who it's for
- Adults who are scheduled for a total knee arthroplasty (knee replacement) because of osteoarthritis.
- What's involved
- Participants will be randomly assigned to receive a corticosteroid injection in the knee opposite the one being replaced, in addition to usual care. They will have clinic visits for the injection and follow‑up assessments of pain and function.
- Time commitment
- The study involves a few clinic visits over several weeks before and after the knee replacement surgery.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.