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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
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Withdrawn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
No
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
No
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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