Clinical trial NCT06809998: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
Official title: COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Total Knee Anthroplasty
Osteoarthritis(Primary)
Osteoarthritis (OA) of the Knee
Bilateral Knee Osteoarthritis
Keywords: COSTI
Total Knee Arthroplasty
Corticosteroid Injection
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple-blind randomized controlled superiority trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: 4-, 8-, 12-weeks and 1-year post-surgery
Secondary outcomes:
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: 4-, 8-, 12-weeks and 1-year post-surgery
measure: EuroQol five-dimensional descriptive system (EQ-5D-5L)
timeFrame: 4-, 8-, 12-weeks and 1-year post-surgery
measure: Knee range of motion (ROM)
timeFrame: 4-, 8-, 12-weeks and 1-year post-surgery
measure: Timed Up Go Test (TUG)
timeFrame: 4-, 8-, 12-weeks and 1-year post-surgery
measure: Forgotten Joint Score (FJS)
timeFrame: 12-weeks and 1-year post-surgery
Other outcomes:
measure: Feasibility - recruitment
timeFrame: 1.5 years
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Amir Khoshbin, MD, FRCS (C)
role: PRINCIPAL_INVESTIGATOR
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