COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

Phase 1

Recruiting

• Conditions: Total Knee Anthroplasty; Osteoarthritis(primary); Osteoarthritis (OA) of the Knee; Bilateral Knee Osteoarthritis
• Interventions: Drug: Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).; Other: Band-Aid

• Registration Number: NCT06809998
• Lead Sponsor: Unity Health Toronto

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study Start: 2025-01-24
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Corticosteroid Injection	Corticosteroid 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). 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.
Group B - Band-Aid Placement	Band-Aid	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.

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score (OKS)	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 Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Pain Score	4-, 8-, 12-weeks and 1-year post-surgery	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)	4-, 8-, 12-weeks and 1-year post-surgery	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)	4-, 8-, 12-weeks and 1-year post-surgery	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)	4-, 8-, 12-weeks and 1-year post-surgery	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
Forgotten Joint Score (FJS)	12-weeks and 1-year post-surgery	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.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada