COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Unity Health Toronto
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Oxford Knee Score (OKS)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
This trial will be triple-blinded, meaning none of the patient, the treating most responsible surgeon or the outcome assessors (i.e. advanced practice physical therapists) will be aware of the treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Band-Aid (Other)
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.
Intervention: Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL). (Drug)
Outcomes
Primary Outcomes
Oxford Knee Score (OKS)
Time Frame: 4-, 8-, 12-weeks and 1-year post-surgery
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.
Secondary Outcomes
- Visual Analogue Scale (VAS) Pain Score(4-, 8-, 12-weeks and 1-year post-surgery)
- EuroQol five-dimensional descriptive system (EQ-5D-5L)(4-, 8-, 12-weeks and 1-year post-surgery)
- Knee range of motion (ROM)(4-, 8-, 12-weeks and 1-year post-surgery)
- Timed Up Go Test (TUG)(4-, 8-, 12-weeks and 1-year post-surgery)
- Forgotten Joint Score (FJS)(12-weeks and 1-year post-surgery)
