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Ultrasound Guided vs Unguided Intra-articular Knee Injections

Primary Purpose

Osteoarthritis, Inflammatory Arthritis

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Ultrasound machine

Unguided injection

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ultrasound Machine Guided Injection

Unguided Injection

Arm Description

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

Needle placement performed without ultrasound machine guidance

Outcomes

Primary Outcome Measures

Accuracy of the initial needle placement into the knee joint.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02092246

First Posted

March 13, 2014

Last Updated

October 13, 2015

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02092246

Brief Title

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty enrolling subjects

Study Start Date

March 2014 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Inflammatory Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound Machine Guided Injection

Arm Type

Active Comparator

Arm Description

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

Arm Title

Unguided Injection

Arm Type

Active Comparator

Arm Description

Needle placement performed without ultrasound machine guidance

Intervention Type

Device

Intervention Name(s)

Ultrasound machine

Other Intervention Name(s)

Philips CX-50 Ultrasound Machine, FUJUFILM SonoSite X-Porte Ultrasound Machine

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Unguided injection

Other Intervention Name(s)

Philips CX-50 Ultrasound Machine, FUJIFILM SonoSite X-Porte Ultrasound Machine

Intervention Description

Needle placement will take place without ultrasound machine guidance

Primary Outcome Measure Information:

Title

Accuracy of the initial needle placement into the knee joint.

Description

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 Outcome Measure Information:

Title

Improved clinical efficacy of US guided knee injections compared to unguided knee injections

Description

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

Other Pre-specified Outcome Measures:

Title

Detection of knee effusions

Description

Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically

Time Frame

During procedure, which can take up to 30 minutes to complete

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Pingree, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ultrasound Guided vs Unguided Intra-articular Knee Injections

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