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Completed

NCT Number: NCT03293238

Ultrasound Guided Knee Injections in Musculoskeletal Medicine

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Joint line ultrasound

Procedure

Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.

Other names: JLUS

Joint line landmark

Procedure

Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.

Other names: JLL

Suprapatellar ultrasound guided

Procedure

Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.

Other names: SPUS

Suprapatellar Landmark

Procedure

Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.

Other names: SPL

Primary outcomes

  1. Number of Participants With Successful Knee Injection

    Time frame: Procedure visit 3 (3-4 weeks after 1st injection)

    To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.

Secondary outcomes

  1. Procedural Satisfaction Score at 3 Months Post Injection

    Time frame: 3 month follow-up appointment following 3rd injection

    Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

    Time frame: Pre-Injection and 3 month follow-up appointment following 3rd injection

    Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Sponsors and collaborators

Lead sponsor

Andrews Research & Education Foundation

Other

Collaborators

  • American Medical Society for Sports Medicine

Registry information

Official study title

Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections

Acronym: PRISMM

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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