NCT07804446

Brief Summary

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:

  1. 1.Be randomly divided into getting their steroid injection on the inside or outside of their knee.
  2. 2.Answer a pain survey before their injection as well as over the phone 2 weeks, 6 weeks, and 12 weeks after their injection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2026May 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

osteoarthritisarthritiscorticosteroidsteroid injectionpainpain controlpain surveykneeknee arthritisknee osteoarthritisknee painknee injection

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    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

    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 Outcomes (2)

  • Institutional Survey on Satisfaction with Injection

    2 weeks, 6 weeks, and 12 weeks post-injection

  • Patient Global Impression of Change

    2 weeks, 6 weeks, and 12 weeks post-injection

Study Arms (2)

Anterolateral

ACTIVE COMPARATOR

These patients will receive their corticosteroid injections on their anterolateral knees.

Procedure: Anterolateral Injection

Anteromedial

ACTIVE COMPARATOR

This group of patients will receive injections on the anteromedial side of their knee.

Procedure: Anteromedial Injection

Interventions

If randomized to this intervention, patients will receive a corticosteroid injection in the anteromedial side of their knee.

Anteromedial

If randomized to this intervention, patients will receive a corticosteroid injection on the anterolateral side of their knee.

Anterolateral

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bolingbrook Clinic

Bolingbrook, Illinois, 60440, United States

RECRUITING

Hyde Park Clinic

Chicago, Illinois, 60637, United States

RECRUITING

La Grange Clinic

La Grange, Illinois, 60525, United States

RECRUITING

Orland Park Clinic

Orland Park, Illinois, 60462, United States

RECRUITING

Woodridge Clinic

Woodridge, Illinois, 60517, United States

RECRUITING

Related Publications (25)

  • 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.

    PMID: 16340590BACKGROUND
  • 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.

    PMID: 15207508BACKGROUND
  • 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.

    PMID: 18055266BACKGROUND
  • 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.

    PMID: 18339561BACKGROUND
  • 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.

    PMID: 23731929BACKGROUND
  • 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.

    PMID: 22036252BACKGROUND
  • 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.

    PMID: 41508090BACKGROUND
  • 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.

    PMID: 26836288BACKGROUND
  • 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.

    PMID: 33901659BACKGROUND
  • 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.

    PMID: 30237904BACKGROUND
  • 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.

    PMID: 24124052BACKGROUND
  • 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.

    PMID: 19491912BACKGROUND
  • 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.

    PMID: 10979111BACKGROUND
  • 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.

    PMID: 21980265BACKGROUND
  • 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.

    PMID: 24462672BACKGROUND
  • 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.

    PMID: 22563589BACKGROUND
  • 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.

    PMID: 34054301BACKGROUND
  • 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.

    PMID: 27992846BACKGROUND
  • 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.

    PMID: 27932358BACKGROUND
  • 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.

    PMID: 21682606BACKGROUND
  • 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.

    PMID: 20706165BACKGROUND
  • Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018 Mar;30(2):160-167. doi: 10.1097/BOR.0000000000000479.

    PMID: 29227353BACKGROUND
  • 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.

    PMID: 32751156BACKGROUND
  • 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.

    PMID: 27015600BACKGROUND
  • 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.

    PMID: 23203864BACKGROUND

MeSH Terms

Conditions

OsteoarthritisArthritisPainAgnosiaOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Sara JS Wallace, M.D./M.P.H.

    The University of Chicago Medical Center

    PRINCIPAL INVESTIGATOR
  • Brandon Pardi, M.D.

    AdventHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malik J Scott, B.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The population will be adults with symptomatic, radiographically moderate-to-severe medial compartment knee osteoarthritis who are already undergoing corticosteroid injections as part of routine care on their native knee. They wil be randomized to receive their injection on either the anteromedial or anterolateral knee.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 4, 2026

Study Start

August 31, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 4, 2026

Record last verified: 2026-08

Locations