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.
Total knee arthroplasty (TKA) is a common and successful procedure used to improve the quality of life and function for patients experiencing debilitating pain from degenerative knee osteoarthritis (OA). Some patients with knee OA have bilateral involvement and surgery may be needed in both knees. Having bilateral knee OA is a known risk factor for dissatisfaction, as there can be an overuse of the less affected, contralateral knee, in order to avoid symptoms from the more severely affected knee. Moreover, one of the principal determinants of patient-reported functional outcome after a unilateral TKA is residual pain and limited function in the contralateral, un-replaced knee. One option to improve range of motion, pain, functional scores and reduce postoperative stiffness on both knees is a bilateral TKA; however, it has been previously reported to have a higher risk of serious cardiac complications, pulmonary complications, and mortality when compared with a unilateral TKA. A less invasive and widely available treatment option is intra-articular corticosteroids applied pre-/peri-operatively in the contralateral (un-replaced) knee to improve post-operative rehabilitation. Intra-articular corticosteroids are extensively used to reduce inflammation and pain in inflamed arthritic joints. They are associated with a moderate improvement in pain and a small improvement in physical function usually up to 3 months after injection. The use of intra-articular corticosteroids in patients with symptomatic knee OA has been shown to improve Visual Analog Scale (VAS) scores at up to 3 months, as well as the WOMAC scores up to 6 months, compared with baseline scores. There is limited data on contralateral steroid injections and its impact on surgical site infection or PROMs. It is estimated that from 6.5% to 20% of patients report early dissatisfaction after knee replacement surgery. Furthermore, having bilateral OA is a known risk factor for dissatisfaction among patients who undergo TKA. Residual pain, limited function and limited range of motion are primary factors in patient satisfaction after undergoing TKA. Therefore, improved pain control in the contralateral knee is hypothesized to play a role in improving patient satisfaction after a TKA on the opposite side, in addition to helping with the post-operative rehabilitation process. Understanding whether contralateral steroid injections confer superior functional and/or patient reported outcome measures after a TKA is critical to enhance patient care and improve patient functional outcomes in OA patients. There is currently a lack of high-quality prospective trials investigating the use of contralateral corticosteroid injections for TKA outcomes. The COSTI trial (Contralateral Steroid Injection in Total Knee Arthroplasty) was developed to fill this knowledge gap. We propose a prospective, triple-blinded (patient, surgeon and outcome assessor), randomized controlled trial comparing contralateral corticosteroid knee injections versus placing a band-aid (control) in patients with bilateral osteoarthritis undergoing a TKA for osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).
Band-Aid
St. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGOxford 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.
Time frame: 4-, 8-, 12-weeks and 1-year post-surgery
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.
Time frame: 4-, 8-, 12-weeks and 1-year post-surgery
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.
Time frame: 4-, 8-, 12-weeks and 1-year post-surgery
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.
Time frame: 4-, 8-, 12-weeks and 1-year post-surgery
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
Time frame: 4-, 8-, 12-weeks and 1-year post-surgery
Forgotten Joint Score (FJS)
A patient-reported outcome measure (PROM) that assesses how well a patient can forget about an affected knee after surgery. 12-question survey that asks patients to rate their awareness of their knee during daily activities. Patients answer each question on a scale of 0-4, with 0 being "never aware" and 4 being "mostly aware". The final score ranges from 0-100, with higher scores indicating less awareness of the knee.
Time frame: 12-weeks and 1-year post-surgery
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