ClinicalTrialsFinder
RecruitingPhase 1Phase 2NCT06809998

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study

Sponsor

Unity Health Toronto

Enrollment

60 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Total Knee Anthroplasty

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria6

  • 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
Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCorticosteroid 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).

OTHERBand-Aid

Band-Aid

Locations(1)

St. Michael's Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06809998

Related Trials

Knee Flexionater to Avoid Motion Restoring Surgery

NCT074543561 location

Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

NCT073667361 location

The Effects of Mir Shakeel Teleintegrated Therapy Plan on Pain, Range of Motion, Gait, Functional Outcomes and Quality of Life in Patients Undergoing Total Knee Arthroplasty

NCT072392581 location

Comparison of Ultrasound-Guided Lumbar ESPB and ACB for Knee Arthroplasty

NCT071157711 location

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

NCT070174001 location