Ultrasound Guided vs Unguided Intra-articular Knee Injections

Study Overview
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Brief Summary
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To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.

Detailed Description
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Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure. Subjects are responsible for all clinical costs associated with the injection. There is no remuneration offered for study participation.

Official Title
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Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population

Conditions
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Osteoarthritis, Inflammatory Arthritis

Intervention / Treatment
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* Device: Ultrasound machine
* Device: Unguided injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria BMI > 30 No clinically detectable knee effusion Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis Must be referred to the Pain Clinic for treatment Exclusion Criteria History of surgery on the affected knee Evidence of untreated systemic infection or systemic immunocompromise Evidence of cutaneous infections near the study knee injection site Patients on warfarin with an INR > 3.0 Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60) History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound Machine Guided Injection<br>Use of ultrasound machine guidance in needle placement into the knee joint | Device: Ultrasound machine<br>* Use of ultrasound machine guidance for accurate needle placement into the knee joint<br>* Other names: FUJUFILM SonoSite X-Porte Ultrasound Machine;|
| Active Comparator: Unguided Injection<br>Needle placement performed without ultrasound machine guidance | Device: Unguided injection<br>* Needle placement will take place without ultrasound machine guidance<br>* Other names: FUJIFILM SonoSite X-Porte Ultrasound Machine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the initial needle placement into the knee joint. | The number of participants with accurate initial needle placement into the knee joint | During the initial needle placement, which can take 1-5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved clinical efficacy of US guided knee injections compared to unguided knee injections | Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't | 30 minutes post injection |