Osteoarthritis, Inflammatory Arthritis
Conditions
Brief summary
To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.
Detailed description
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.
Interventions
DEVICEUltrasound machine
Use of ultrasound machine guidance for accurate needle placement into the knee joint
DEVICEUnguided injection
Needle placement will take place without ultrasound machine guidance
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the initial needle placement into the knee joint. | During the initial needle placement, which can take 1-5 minutes | The number of participants with accurate initial needle placement into the knee joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved clinical efficacy of US guided knee injections compared to unguided knee injections | 30 minutes post injection | Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't |
Other
| Measure | Time frame | Description |
|---|---|---|
| Detection of knee effusions | During procedure, which can take up to 30 minutes to complete | Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically |
Countries
United States
Outcome results
None listed