deltatrials
Recruiting INTERVENTIONAL NCT06809998

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty (COSTI)

COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study

Sponsor: Unity Health Toronto

Updated 4 times since 2025 Last updated: Apr 29, 2026 Started: Jan 24, 2025 Primary completion: Jul 30, 2026 Completion: Jul 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Bilateral Knee Osteoarthritis and Osteoarthritis (OA) of the Knee, this trial is actively recruiting participants. The trial is conducted by Unity Health Toronto and has accumulated 4 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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...

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.

Status Flow

~Mar 2025 – ~Jun 2025 · 3 months · monthly snapshotRecruiting~Jun 2025 – ~Jan 2026 · 7 months · monthly snapshotRecruiting~Jan 2026 – ~May 2026 · 4 months · monthly snapshotRecruitingMay 4, 2026 – present · 4 months · daily APIRecruiting

Change History

4 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1/PHASE2None

  2. Jan 2026 — May 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jun 2025 — Jan 2026 [monthly]

    Recruiting PHASE1/PHASE2

  4. Mar 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

    First recorded

Jan 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Unity Health Toronto
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations