COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About 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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators