Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06809998

COSTI: Contralateral Corticosteroid Injection in Total Knee Arthroplasty - A Triple-Blinded Randomized Controlled Pilot Study

Led by Unity Health Toronto · Updated on 2026-05-01

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether injecting corticosteroids into the knee opposite to the one undergoing total knee arthroplasty (TKA) can improve pain and function for patients with bilateral knee osteoarthritis (OA). This pilot study is a triple-blinded, randomized controlled trial focused on assessing the effectiveness of peri-operative corticosteroid injections compared to a control using a band-aid. The study addresses the problem of residual pain and limited function in the non-operated knee, which can affect patient satisfaction after unilateral TKA. Participants will receive either an injection of 80mg methylprednisolone with bupivacaine into the contralateral knee after spinal anesthesia or a band-aid as a sham comparator. The injection is administered under ultrasound guidance by an anesthesiologist after spinal neuraxial blockage has been given. This intervention aims to reduce inflammation and improve post-operative recovery and rehabilitation without the risks associated with bilateral TKA surgery. During the study, participants will be assessed at 4, 8, 12 weeks and 1 year after surgery using measures including the Oxford Knee Score, Visual Analogue Scale for pain, EuroQol five-dimensional health questionnaire, knee range of motion, Timed Up Go test, and Forgotten Joint Score. Researchers will monitor patient-reported outcomes and functional improvements to determine if the corticosteroid injection provides better results. The study expects to complete by mid-2027.

CONDITIONS

Brief Title

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age and older
  • Diagnosed with primary osteoarthritis and scheduled for primary elective unilateral total knee arthroplasty
  • No corticosteroid or biologic injections in the opposite knee within one year prior to the study
  • Not scheduled for bilateral or staged contralateral total knee arthroplasty within the next six months
  • No previous or active infection or trauma in the opposite knee
  • Opposite knee pain with a Visual Analogue Scale score greater than 4 out of 10 at initial pre-operative visit
  • Opposite knee osteoarthritis graded between 2 and 4 by Kellgren and Lawrence scale
  • Able to read and understand English and provide informed consent
Not Eligible

You will not qualify if you...

  • Osteoarthritis due to other causes such as inflammatory or post-traumatic arthritis
  • Cognitive impairment preventing completion of outcome measures or follow-up
  • Previous total knee arthroplasty, open reduction internal fixation, or nailing on either knee
  • Previous or active infection or extensor mechanism damage in either knee
  • Previous arthroscopy on either knee
  • Medical contraindications to elective total knee arthroplasty surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive either a corticosteroid injection or a sham band-aid application in the contralateral knee during the surgery visit, alongside their total knee arthroplasty procedure.

1 visit (in-person)

Follow-up

Duration - Up to 1 year post-surgery

Participants are monitored for recovery and outcomes including knee function, pain, and quality of life after surgery.

Visits at 4, 8, 12 weeks and 1 year post-surgery

Trial Site Locations

Total: 1 location

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

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Research Team

C

Cassandra Tardif-Theriault, BKin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Efficacy and Treatment Response of Intra-articular Corticosteroid Injections in Patients With Symptomatic Knee Osteoarthritis.

Elizabeth G Matzkin, Emily J Curry, Qingwu Kong...

https://pubmed.ncbi.nlm.nih.gov/28953085

Intra-articular injection of methylprednisolone for reducing pain in knee osteoarthritis: A systematic review and meta-analysis.

Kewei Tian, Huiguang Cheng, Jiangtao Zhang...

https://pubmed.ncbi.nlm.nih.gov/29642145

Comparison of clinical outcome between simultaneous-bilateral and staged-bilateral total knee arthroplasty: a systematic review of retrospective studies.

Dong Fu, Guodong Li, Kai Chen...

https://pubmed.ncbi.nlm.nih.gov/23518424

Postoperative Stiffness Requiring Manipulation Under Anesthesia Is Significantly Reduced After Simultaneous Versus Staged Bilateral Total Knee Arthroplasty.

John P Meehan, Shafagh Monazzam, Troy Miles...

https://pubmed.ncbi.nlm.nih.gov/29257014

The rate and predictors of patient satisfaction after total knee arthroplasty are influenced by the focus of the question: a standard satisfaction question is required.

N D Clement, M Bardgett, D Weir...

https://pubmed.ncbi.nlm.nih.gov/29855236