Recruiting
Phase 1
Phase 2

Corticosteroid Injection

Sponsor:

Unity Health Toronto

Code:

NCT06809998

Conditions

Total Knee Anthroplasty

Osteoarthritis(Primary)

Osteoarthritis (OA) of the Knee

Bilateral Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).

Band-Aid

Study Details

Brief summary:

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.

Conditions

Total Knee Anthroplasty

Osteoarthritis(Primary)

Osteoarthritis (OA) of the Knee

Bilateral Knee Osteoarthritis

Study ID

NCT06809998

Start date

Jan 24, 2025

Status verified date

Apr, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A - Corticosteroid Injection

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.

sham comparator: Group B - Band-Aid Placement

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.

Interventions

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).

Band-Aid

Band-Aid

Primary outcome measure

  • Oxford Knee Score (OKS) [ Time Frame: 4-, 8-, 12-weeks and 1-year post-surgery ]

Central Contacts and Locations

Central contacts

Cassandra Tardif-Theriault, BKin

416-864-6060cassandra.tardif-theriault@unityhealth.to

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Amir Khoshbin, MD, FRCS (C)

416-864-5265amir.khoshbin@unityhealth.to

Cassandra Tardif-Theriault, BKin

416-864-6060cassandra.tardif-theriault@unityhealth.to

Principal Investigator:

Amir Khoshbin, MD, FRCS (C)

More Information

Sponsor

Unity Health Toronto

Last update posted

Jul 30, 2026

Last verified

Apr, 2026

Keywords

  • COSTI
  • Total Knee Arthroplasty
  • Corticosteroid Injection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-07-30.