Ultrasound Guided vs Unguided Intra-articular Knee Injections

NCT02092246 | Withdrawn Phase 3

• 1 other identifier: 13-008328
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis; Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  30 minutes post injection

Other Outcomes (1)

• Detection of knee effusions

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

Study Arms (2)

Ultrasound Machine Guided Injection

ACTIVE COMPARATOR

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

Device: Ultrasound machine

Unguided Injection

ACTIVE COMPARATOR

Needle placement performed without ultrasound machine guidance

Device: Unguided injection

Interventions

Ultrasound machine DEVICE

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

Also known as: Philips CX-50 Ultrasound Machine, FUJUFILM SonoSite X-Porte Ultrasound Machine

Ultrasound Machine Guided Injection

Unguided injection DEVICE

Needle placement will take place without ultrasound machine guidance

Also known as: Philips CX-50 Ultrasound Machine, FUJIFILM SonoSite X-Porte Ultrasound Machine

Unguided Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Matthew Pingree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 20, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

US (1)