Ultrasound Guided Knee Injections in Musculoskeletal Medicine (PRISMM)

Andrews Research & Education Foundation

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Procedure: Joint line landmark; Procedure: Suprapatellar Landmark; Procedure: Suprapatellar ultrasound guided; Procedure: Joint line ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03293238

PRISMM-Knee

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 4 patient groups

Joint Line Ultrasound

Active Comparator group

Description:

Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.

Treatment:

Procedure: Joint line ultrasound

Joint Line Landmark

Sham Comparator group

Description:

Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.

Treatment:

Procedure: Joint line landmark

Suprapatellar Ultrasound Guided

Active Comparator group

Description:

Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.

Treatment:

Procedure: Suprapatellar ultrasound guided

Suprapatellar Landmark

Sham Comparator group

Description:

Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.

Treatment:

Procedure: Suprapatellar Landmark