Ultrasound Guided vs Unguided Intra-articular Knee Injections

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02092246
• Other study ID #: 13-008328
• Status: Withdrawn
• Phase: Phase 3
• First received: March 13, 2014
• Last updated: October 13, 2015
• Start date: March 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis
• Osteoarthritis

Intervention

Device:
• Ultrasound machine
Use of ultrasound machine guidance for accurate needle placement into the knee joint
• Unguided injection
Needle placement will take place without ultrasound machine guidance

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No