Corticosteroid Injection for Knee Arthritis (COSTI Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByAmir Khoshbin, MD, FRCS (C)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Unity Health Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with knee osteoarthritis who are scheduled for total knee replacement surgery. Participants should not have any known allergies to corticosteroids or bupivacaine, and must be willing to undergo the study procedures.

Inclusion Criteria

I am diagnosed with osteoarthritis and need a knee replacement.

My other knee has no infections, injuries, or trauma.

I have pain in the opposite knee with a score over 4 out of 10.

I am not planning to have knee replacement surgery on both sides within 6 months.

Exclusion Criteria

I have had knee surgery, such as a total knee replacement or fracture repair.

I have had knee surgery before.

I have had or currently have a knee infection or a problem with my knee's extensor mechanism.

I cannot have knee replacement surgery due to health reasons.

Participant Groups

The study tests if a corticosteroid injection in the opposite knee can help reduce pain and improve function after knee replacement surgery. It's a triple-blinded trial, meaning neither patients, doctors nor assessors know who receives the real treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A - Corticosteroid InjectionExperimental Treatment1 Intervention

Corticosteroid injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL). The patient will be brought to the regional room where a fully licensed anaesthesiologist will perform standard of care anaesthesia followed by an ultrasound guided intra-articular knee injection with steroid AFTER the spinal neuraxial blockage has already been administered.

Group II: Group B - Band-Aid PlacementPlacebo Group1 Intervention

The patient will be brought to the regional room where a fellowship trained interventional pain/regional anaesthesiologist will perform standard of care anaesthesia followed by the application of a band-aid.