Clinical trial NCT02092246: Ultrasound Guided vs Unguided Intra-articular Knee Injections
Official title: Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Osteoarthritis
Inflammatory Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the initial needle placement into the knee joint.
timeFrame: During the initial needle placement, which can take 1-5 minutes
Secondary outcomes:
measure: Improved clinical efficacy of US guided knee injections compared to unguided knee injections
timeFrame: 30 minutes post injection
Other outcomes:
measure: Detection of knee effusions
timeFrame: During procedure, which can take up to 30 minutes to complete
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Pingree, MD
role: PRINCIPAL_INVESTIGATOR
References: