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.
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
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
Parallel
Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).
DrugCorticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).
Band-Aid
Other interventionBand-Aid
Oxford Knee Score (OKS)
Repeated mean score of a short questionnaire consisting of 12 questions ranging from 0 to 48 points, designed to assess function and pain after knee replacement surgery. Higher values represent a better outcome.
Visual Analogue Scale (VAS) Pain Score
Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten). Assess both the operative and injected knees.
EuroQol five-dimensional descriptive system (EQ-5D-5L)
The European Quality of Life 5 Dimensions (EQ5D) is a patient reported outcome where patients self rate their level of severity of health status and health related quality of life. Consists of 5 dimensions (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Knee range of motion (ROM)
The therapist/assessor uses a goniometer (instrument that measures an angle of a joint) to measure the degree of knee flexion and extension of a patient. Knee ROM of both the operated and injected knees will be taken. Knee Flexion - the measurable degree in which the leg (and knee joint) is bent. Knee Extension - The measurable degree in which the knee is extended (making the joint angle larger, or straightening the knee.
Timed Up Go Test (TUG)
TUG is a simple test used to assess a person's mobility (in seconds) and requires both static and dynamic balance. A line is placed on the floor 3 meters away from a chair where patient will be sitting. When instructed to "GO" patient will stand, walk to a line on the floor at his/her regular pace, turn around and walk back to the chair and sit down. The longer it takes for subject to complete the test, higher is the risk of fall and lower is the its functional mobility. Reference values are: 60-69 years old = 8.1 seconds; 70-79 years old = 9.2 seconds; 80-99 years old = 11.3 seconds. Over 14 seconds is associate with high risk of fall
Feasibility - recruitment
Ability to recruit 60 patients.
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