COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

NCT06809998 | Recruiting Phase 1

• 1 other identifier: 24-158
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis(Primary); Total Knee Anthroplasty; Osteoarthritis (OA) of the Knee; Bilateral Knee Osteoarthritis

Keywords

COSTI; Total Knee Arthroplasty; Corticosteroid Injection

Outcome Measures

Primary Outcomes (1)

• Oxford 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.

  4-, 8-, 12-weeks and 1-year post-surgery

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Feasibility - recruitment

  1.5 years

Study Arms (2)

Group A - Corticosteroid Injection

EXPERIMENTAL

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.

Drug: Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).

Group B - Band-Aid Placement

SHAM COMPARATOR

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.

Other: Band-Aid

Interventions

Band-Aid OTHER

Band-Aid

Group B - Band-Aid Placement

Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL). DRUG

Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).

Group A - Corticosteroid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (15)

• Matzkin EG, Curry EJ, Kong Q, Rogers MJ, Henry M, Smith EL. Efficacy and Treatment Response of Intra-articular Corticosteroid Injections in Patients With Symptomatic Knee Osteoarthritis. J Am Acad Orthop Surg. 2017 Oct;25(10):703-714. doi: 10.5435/JAAOS-D-16-00541.

  PMID: 28953085 BACKGROUND

• da Costa BR, Hari R, Juni P. Intra-articular Corticosteroids for Osteoarthritis of the Knee. JAMA. 2016 Dec 27;316(24):2671-2672. doi: 10.1001/jama.2016.17565.

  PMID: 28027351 BACKGROUND

• Tian K, Cheng H, Zhang J, Chen K. Intra-articular injection of methylprednisolone for reducing pain in knee osteoarthritis: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Apr;97(15):e0240. doi: 10.1097/MD.0000000000010240.

  PMID: 29642145 BACKGROUND

• Fu D, Li G, Chen K, Zeng H, Zhang X, Cai Z. Comparison of clinical outcome between simultaneous-bilateral and staged-bilateral total knee arthroplasty: a systematic review of retrospective studies. J Arthroplasty. 2013 Aug;28(7):1141-7. doi: 10.1016/j.arth.2012.09.023. Epub 2013 Mar 19.

  PMID: 23518424 BACKGROUND

• Restrepo C, Parvizi J, Dietrich T, Einhorn TA. Safety of simultaneous bilateral total knee arthroplasty. A meta-analysis. J Bone Joint Surg Am. 2007 Jun;89(6):1220-6. doi: 10.2106/JBJS.F.01353.

  PMID: 17545424 BACKGROUND

• Sheth DS, Cafri G, Paxton EW, Namba RS. Bilateral Simultaneous vs Staged Total Knee Arthroplasty: A Comparison of Complications and Mortality. J Arthroplasty. 2016 Sep;31(9 Suppl):212-6. doi: 10.1016/j.arth.2016.03.018. Epub 2016 Mar 17.

  PMID: 27430183 BACKGROUND

• Bagsby D, Pierson JL. Functional outcomes of simultaneous bilateral versus unilateral total knee arthroplasty. Orthopedics. 2015 Jan;38(1):e43-7. doi: 10.3928/01477447-20150105-59.

  PMID: 25611419 BACKGROUND

• Meehan JP, Monazzam S, Miles T, Danielsen B, White RH. Postoperative Stiffness Requiring Manipulation Under Anesthesia Is Significantly Reduced After Simultaneous Versus Staged Bilateral Total Knee Arthroplasty. J Bone Joint Surg Am. 2017 Dec 20;99(24):2085-2093. doi: 10.2106/JBJS.17.00130.

  PMID: 29257014 BACKGROUND

• Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.

  PMID: 28844632 BACKGROUND

• Clement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. The rate and predictors of patient satisfaction after total knee arthroplasty are influenced by the focus of the question: a standard satisfaction question is required. Bone Joint J. 2018 Jun 1;100-B(6):740-748. doi: 10.1302/0301-620X.100B6.BJJ-2017-1292.R1.

  PMID: 29855236 BACKGROUND

• Huang S, Li X, Tang Y, Stiphan S, Yan B, He P, Xu D. Different patient satisfaction levels between the first and second knee in the early stage after simultaneous bilateral total knee arthroplasty (TKA): a comparison between subjective and objective outcome assessments. J Orthop Surg Res. 2017 Jul 26;12(1):121. doi: 10.1186/s13018-017-0605-0.

  PMID: 28747231 BACKGROUND

• Walmsley P, Murray A, Brenkel IJ. The practice of bilateral, simultaneous total knee replacement in Scotland over the last decade. Data from the Scottish Arthroplasty Project. Knee. 2006 Mar;13(2):102-5. doi: 10.1016/j.knee.2006.01.003. Epub 2006 Feb 14.

  PMID: 16481171 BACKGROUND

• Marmon AR, Zeni JA Jr, Snyder-Mackler L. Perception and presentation of function in patients with unilateral versus bilateral knee osteoarthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):406-13. doi: 10.1002/acr.21825.

  PMID: 22933450 BACKGROUND

• Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.

  PMID: 16967035 BACKGROUND

• Lim JB, Chou AC, Chong HC, Lo NN, Chia SL, Tay KJ, Yeo SJ. Are patients more satisfied and have better functional outcome after bilateral total knee arthroplasty as compared to total hip arthroplasty and unilateral total knee arthroplasty surgery? A two-year follow-up study. Acta Orthop Belg. 2015 Dec;81(4):682-9.

  PMID: 26790791 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex Hormones; Methylprednisolone; Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Amir Khoshbin, MD, FRCS (C)

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Tardif-Theriault, BKin

CONTACT

416-864-6060; cassandra.tardif-theriault@unityhealth.to

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Triple-blind randomized controlled superiority trial

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 5, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)