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:

  1. Be randomly divided into getting their steroid injection on the inside or outside of their knee.
  2. 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Bolingbrook, Illinois, United States, 60440
        • Recruiting
        • Bolingbrook Clinic
        • Contact:
        • Principal Investigator:
          • Brandon Pardi, M.D.
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Hyde Park Clinic
        • Contact:
        • Contact:
        • 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:
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • Orland Park Clinic
        • Principal Investigator:
          • Sara JS Wallace, M.D./M.P.H.
        • Contact:
        • Contact:
      • Woodridge, Illinois, United States, 60517
        • Recruiting
        • Woodridge Clinic
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Anterolateral
These patients will receive their corticosteroid injections on their anterolateral knees.
Procedure: Anterolateral Injection
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.
Procedure: Anteromedial Injection
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AdventHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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