- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07804446
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection (Medial OA CSI)
August 31, 2026 updated by: University of Chicago
Does Injection Site (Anteromedial vs Anterolateral) Affect Pain Relief After Intra-Articular Corticosteroid Injection in Moderate-to-Severe Medial Knee Osteoarthritis?
The primary purpose of this study is to find out if there is a difference in pain experienced in patients with knee arthritis of the inside of their knee if they get a steroid injection on the inside or outside of their knee. Participants will:
- Be randomly divided into getting their steroid injection on the inside or outside of their knee.
- Answer a pain survey before their injection as well as over the phone 2 weeks, 6 weeks, and 12 weeks after their injection.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Malik J Scott, B.A.
- Phone Number: 773-834-3531
- Email: mjscott1@uchicago.edu
Study Locations
-
-
Illinois
-
Bolingbrook, Illinois, United States, 60440
- Recruiting
- Bolingbrook Clinic
-
Contact:
- Brandon Pardi, M.D.
- Phone Number: 630-759-1248
- Email: brandon.pardi.md@adventhealth.com
-
Principal Investigator:
- Brandon Pardi, M.D.
-
Chicago, Illinois, United States, 60637
- Recruiting
- Hyde Park Clinic
-
Contact:
- Sara J Wallace, M.D./M.P.H.
- Phone Number: 773-834-3531
- Email: swallace2@bsd.uchicago.edu
-
Contact:
- Malik Scott, B.A.
- Email: mjscott1@uchicago.edu
-
Principal Investigator:
- Sara JS Wallace, M.D./M.P.H.
-
La Grange, Illinois, United States, 60525
- Recruiting
- La Grange Clinic
-
Principal Investigator:
- Sara JS Wallace, M.D./M.P.H.
-
Contact:
- Sara JS Wallace, M.D./M.P.H.
- Phone Number: 773-834-3531
- Email: swallace2@bsd.uchicago.edu
-
Orland Park, Illinois, United States, 60462
- Recruiting
- Orland Park Clinic
-
Principal Investigator:
- Sara JS Wallace, M.D./M.P.H.
-
Contact:
- Sara JS Wallace, M.D./M.P.H.
- Phone Number: 888-824-0200
- Email: swallace2@bsd.uchicago.edu
-
Contact:
- Malik J Scott, B.A.
- Email: mjscott1@uchicago.edu
-
Woodridge, Illinois, United States, 60517
- Recruiting
- Woodridge Clinic
-
Contact:
- Brandon Pardi, M.D.
- Phone Number: 630-759-1248
- Email: brandon.pardi.md@adventhealth.com
-
Principal Investigator:
- Brandon Pardi, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 40
- Clinical diagnosis of knee OA with predominant medial compartment symptoms
- Radiographic moderate-to-severe medial compartment OA (KL grade 3-4 or equivalent)
- Agreed to and preparing to receive a CSI of the knee as part of standard care from surgeon, regardless of past injection of the knee
- Able to provide informed consent
- Able to complete phone, email, or MyChart follow-ups in English
Exclusion Criteria:
- Predominant lateral compartment OA or patellofemoral-only OA
- Inflammatory arthritis (RA, gout flare, etc.)
- Suspected or confirmed joint infection or overlying cellulitis
- Prior knee arthroplasty on the index knee
- Planned surgery for index knee within 12-week follow-up
- Inability to complete follow-up assessments
- Other clinician-determined contraindication to CSI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Anterolateral
These patients will receive their corticosteroid injections on their anterolateral knees.
|
If randomized to this intervention, patients will receive a corticosteroid injection on the anterolateral side of their knee.
|
|
Active Comparator: Anteromedial
This group of patients will receive injections on the anteromedial side of their knee.
|
If randomized to this intervention, patients will receive a corticosteroid injection in the anteromedial side of their knee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: Pre-procedure, 2 weeks, 6 weeks, and 12 weeks post-injection
|
This survey asks patients to rate their pain on a scale from 0 to 10.
|
Pre-procedure, 2 weeks, 6 weeks, and 12 weeks post-injection
|
|
Knee Osteoarthritis and Outcome Score-Joint Replacement
Time Frame: Pre-procedure, 2 weeks, 6 weeks, and 12 weeks post-injection
|
This standardized survey asks patients to describe the impact of their knee stiffness and pain on daily tasks.
|
Pre-procedure, 2 weeks, 6 weeks, and 12 weeks post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Institutional Survey on Satisfaction with Injection
Time Frame: 2 weeks, 6 weeks, and 12 weeks post-injection
|
This survey asks patients to rate their satisfaction with their corticosteroid injection on a scale from 0 to 10.
|
2 weeks, 6 weeks, and 12 weeks post-injection
|
|
Patient Global Impression of Change
Time Frame: 2 weeks, 6 weeks, and 12 weeks post-injection
|
This survey asks patients to rate their overall health status on a scale from 1 to 7.
|
2 weeks, 6 weeks, and 12 weeks post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara JS Wallace, M.D./M.P.H., The University of Chicago Medical Center
- Principal Investigator: Brandon Pardi, M.D., AdventHealth
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
- Losina E, Weinstein AM, Reichmann WM, Burbine SA, Solomon DH, Daigle ME, Rome BN, Chen SP, Hunter DJ, Suter LG, Jordan JM, Katz JN. Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US. Arthritis Care Res (Hoboken). 2013 May;65(5):703-11. doi: 10.1002/acr.21898.
- Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
- Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
- Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692.
- van Middelkoop M, Arden NK, Atchia I, Birrell F, Chao J, Rezende MU, Lambert RG, Ravaud P, Bijlsma JW, Doherty M, Dziedzic KS, Lohmander LS, McAlindon TE, Zhang W, Bierma-Zeinstra SM. The OA Trial Bank: meta-analysis of individual patient data from knee and hip osteoarthritis trials show that patients with severe pain exhibit greater benefit from intra-articular glucocorticoids. Osteoarthritis Cartilage. 2016 Jul;24(7):1143-52. doi: 10.1016/j.joca.2016.01.983. Epub 2016 Feb 2.
- Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018 Mar;30(2):160-167. doi: 10.1097/BOR.0000000000000479.
- Wright EA, Katz JN, Cisternas MG, Kessler CL, Wagenseller A, Losina E. Impact of knee osteoarthritis on health care resource utilization in a US population-based national sample. Med Care. 2010 Sep;48(9):785-91. doi: 10.1097/MLR.0b013e3181e419b1.
- Wylde V, Beswick A, Bruce J, Blom A, Howells N, Gooberman-Hill R. Chronic pain after total knee arthroplasty. EFORT Open Rev. 2018 Aug 16;3(8):461-470. doi: 10.1302/2058-5241.3.180004. eCollection 2018 Aug.
- Hanley MA, Jensen MP, Ehde DM, Robinson LR, Cardenas DD, Turner JA, Smith DG. Clinically significant change in pain intensity ratings in persons with spinal cord injury or amputation. Clin J Pain. 2006 Jan;22(1):25-31. doi: 10.1097/01.ajp.0000148628.69627.82.
- Toda Y, Tsukimura N. A comparison of intra-articular hyaluronan injection accuracy rates between three approaches based on radiographic severity of knee osteoarthritis. Osteoarthritis Cartilage. 2008 Sep;16(9):980-5. doi: 10.1016/j.joca.2008.01.003. Epub 2008 Mar 12.
- Courtney P, Doherty M. Joint aspiration and injection and synovial fluid analysis. Best Pract Res Clin Rheumatol. 2013 Apr;27(2):137-69. doi: 10.1016/j.berh.2013.02.005.
- Hermans J, Bierma-Zeinstra SM, Bos PK, Verhaar JA, Reijman M. The most accurate approach for intra-articular needle placement in the knee joint: a systematic review. Semin Arthritis Rheum. 2011 Oct;41(2):106-15. doi: 10.1016/j.semarthrit.2011.02.007.
- Huang Y, Liu P. Expert consensus on glucocorticoids injection for knee osteoarthritis. J Orthop Surg Res. 2026 Jan 8;21(1):25. doi: 10.1186/s13018-025-06363-1.
- Najm A, Alunno A, Gwinnutt JM, Weill C, Berenbaum F. Efficacy of intra-articular corticosteroid injections in knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Joint Bone Spine. 2021 Jul;88(4):105198. doi: 10.1016/j.jbspin.2021.105198. Epub 2021 Apr 24.
- Waimann CA, Fernandez-Mazarambroz RJ, Cantor SB, Lopez-Olivo MA, Zhang H, Landon GC, Siff SJ, Suarez-Almazor ME. Cost-effectiveness of total knee replacement: a prospective cohort study. Arthritis Care Res (Hoboken). 2014 Apr;66(4):592-9. doi: 10.1002/acr.22186.
- Lutzner J, Kasten P, Gunther KP, Kirschner S. Surgical options for patients with osteoarthritis of the knee. Nat Rev Rheumatol. 2009 Jun;5(6):309-16. doi: 10.1038/nrrheum.2009.88.
- Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, Burr AM, Zhao WW, Kent JD, Lefkowith JB, Verburg KM, Geis GS. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA. 2000 Sep 13;284(10):1247-55. doi: 10.1001/jama.284.10.1247.
- McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med. 2011 Sep;8(9):e1001098. doi: 10.1371/journal.pmed.1001098. Epub 2011 Sep 27.
- Bedenbaugh AV, Bonafede M, Marchlewicz EH, Lee V, Tambiah J. Real-World Health Care Resource Utilization and Costs Among US Patients with Knee Osteoarthritis Compared with Controls. Clinicoecon Outcomes Res. 2021 May 21;13:421-435. doi: 10.2147/CEOR.S302289. eCollection 2021.
- Kye SY, Park K. Suicidal ideation and suicidal attempts among adults with chronic diseases: A cross-sectional study. Compr Psychiatry. 2017 Feb;73:160-167. doi: 10.1016/j.comppsych.2016.12.001. Epub 2016 Dec 14.
- Veronese N, Stubbs B, Solmi M, Smith TO, Noale M, Cooper C, Maggi S. Association between lower limb osteoarthritis and incidence of depressive symptoms: data from the osteoarthritis initiative. Age Ageing. 2017 May 1;46(3):470-476. doi: 10.1093/ageing/afw216.
- Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis. J Med Econ. 2011;14(4):497-507. doi: 10.3111/13696998.2011.594347. Epub 2011 Jun 20.
- He Y, Li Z, Alexander PG, Ocasio-Nieves BD, Yocum L, Lin H, Tuan RS. Pathogenesis of Osteoarthritis: Risk Factors, Regulatory Pathways in Chondrocytes, and Experimental Models. Biology (Basel). 2020 Jul 29;9(8):194. doi: 10.3390/biology9080194.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
August 31, 2026
First Submitted That Met QC Criteria
August 31, 2026
First Posted (Actual)
September 4, 2026
Study Record Updates
Last Update Posted (Actual)
September 4, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB26-0169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
IPD may not be shared due to privacy concerns, but the authors will consider sharing de-identified data upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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