Clinical trial NCT03293238: Ultrasound Guided Knee Injections in Musculoskeletal Medicine
Official title: Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
osteoarthritis
ultrasound
sonography
injection
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: American Medical Society for Sports Medicine (AMSSM)
First posted: 2017-09-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
Primary purpose: TREATMENT

Brief summary: This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.

Detailed description: This study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. Historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. Newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 to 90
* Clinician determined need for intra-articular knee injection
* Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale

Exclusion Criteria:

* Allergy to contrast dye, shellfish
* Allergy to egg product or hyaluronate
* Allergy to lidocaine
* Localized skin infection at planned site of injection
* Inability to complete follow-up phone call three months following the injection
* Viscosupplementation injection within 6 months of the current evaluation

Primary outcomes:
measure: Number of Participants With Successful Knee Injection
timeFrame: Procedure visit 3 (3-4 weeks after 1st injection)
Secondary outcomes:
measure: Procedural Satisfaction Score at 3 Months Post Injection
timeFrame: 3 month follow-up appointment following 3rd injection
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
timeFrame: Pre-Injection and 3 month follow-up appointment following 3rd injection
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
Study officials:
affiliation: Andrews Institute for Orthopaedic & Sports Medicine
name: Joshua Hackel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
citation: Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.
citation: Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.