Ultrasound Guided vs Unguided Intra-articular Knee Injections

Phase 3WithdrawnNCT02092246

Mayo Clinic

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Osteoarthritis Inflammatory Arthritis

Interventions

Ultrasound machineDEVICE

Use of ultrasound machine guidance for accurate needle placement into the knee joint

Unguided injectionDEVICE

Needle placement will take place without ultrasound machine guidance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Accuracy of the initial needle placement into the knee joint.

The number of participants with accurate initial needle placement into the knee joint

Time frame: During the initial needle placement, which can take 1-5 minutes

Secondary Outcomes

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

Time frame: 30 minutes post injection

Data from ClinicalTrials.gov

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