Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
80

Inclusion Criteria

No clinically detectable knee effusion
Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
Must be referred to the Pain Clinic for treatment
...
No clinically detectable knee effusion
Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
Must be referred to the Pain Clinic for treatment
BMI > 30

Exclusion Criteria

Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
Patients on warfarin with an INR > 3.0
Evidence of untreated systemic infection or systemic immunocompromise
...
Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
Patients on warfarin with an INR > 3.0
Evidence of untreated systemic infection or systemic immunocompromise
Evidence of cutaneous infections near the study knee injection site
History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
History of surgery on the affected knee

Summary

Conditions
  • Inflammatory Arthritis
  • Osteoarthritis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 guida...

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.

Inclusion Criteria

No clinically detectable knee effusion
Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
Must be referred to the Pain Clinic for treatment
...
No clinically detectable knee effusion
Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
Must be referred to the Pain Clinic for treatment
BMI > 30

Exclusion Criteria

Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
Patients on warfarin with an INR > 3.0
Evidence of untreated systemic infection or systemic immunocompromise
...
Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
Patients on warfarin with an INR > 3.0
Evidence of untreated systemic infection or systemic immunocompromise
Evidence of cutaneous infections near the study knee injection site
History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
History of surgery on the affected knee

Tracking Information

NCT #
NCT02092246
Collaborators
Not Provided
Investigators
  • Principal Investigator: Matthew Pingree, MD Mayo Clinic
  • Matthew Pingree, MD Mayo Clinic