Ultrasound Guided vs Unguided Intra-articular Knee Injections

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

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

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Inflammatory Arthritis
• Intervention / Treatment: Device: Ultrasound machine; Device: Unguided injection

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound Machine Guided Injection; Use of ultrasound machine guidance in needle placement into the knee joint	Device: Ultrasound machine; Use of ultrasound machine guidance for accurate needle placement into the knee joint; Other Names: Philips CX-50 Ultrasound Machine; FUJUFILM SonoSite X-Porte Ultrasound Machine
Active Comparator: Unguided Injection; Needle placement performed without ultrasound machine guidance	Device: Unguided injection; Needle placement will take place without ultrasound machine guidance; Other Names: Philips CX-50 Ultrasound Machine; FUJIFILM SonoSite X-Porte Ultrasound Machine

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of knee effusions	Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically	During procedure, which can take up to 30 minutes to complete

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Pingree, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 13-008328