Ultrasound Guided vs Unguided Intra-articular Knee Injections

NCT ID: NCT02092246

Last Updated: 2015-10-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Osteoarthritis; Inflammatory Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasound Machine Guided Injection

Use of ultrasound machine guidance in needle placement into the knee joint

Group Type: ACTIVE_COMPARATOR

Ultrasound machine

Intervention Type: DEVICE

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

Unguided Injection

Needle placement performed without ultrasound machine guidance

Group Type: ACTIVE_COMPARATOR

Unguided injection

Intervention Type: DEVICE

Needle placement will take place without ultrasound machine guidance

Interventions

Ultrasound machine

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

Intervention Type: DEVICE

Unguided injection

Needle placement will take place without ultrasound machine guidance

Intervention Type: DEVICE

Other Intervention Names

Philips CX-50 Ultrasound Machine; FUJUFILM SonoSite X-Porte Ultrasound Machine; Philips CX-50 Ultrasound Machine; FUJIFILM SonoSite X-Porte Ultrasound Machine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew Pingree

Assistant Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Pingree, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

13-008328

Identifier Type: -

Identifier Source: org_study_id