Ultrasound Guided Knee Injections in Musculoskeletal Medicine

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

Detailed Description
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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.

Official Title
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Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Joint line ultrasound
* Procedure: Joint line landmark
* Procedure: Suprapatellar ultrasound guided
* Procedure: Suprapatellar Landmark


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Joint Line Ultrasound<br>Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. | Procedure: Joint line ultrasound<br>* 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.<br>* Other names: JLUS;|
| Sham Comparator: Joint Line Landmark<br>Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. | Procedure: Joint line landmark<br>* 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.<br>* Other names: JLL;|
| Active Comparator: Suprapatellar Ultrasound Guided<br>Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. | Procedure: Suprapatellar ultrasound guided<br>* 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.<br>* Other names: SPUS;|
| Sham Comparator: Suprapatellar Landmark<br>Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance. | Procedure: Suprapatellar Landmark<br>* 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.<br>* Other names: SPL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Knee 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. | Procedure visit 3 (3-4 weeks after 1st injection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Satisfaction Score at 3 Months Post Injection | Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure. | 3 month follow-up appointment following 3rd injection | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | 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. | Pre-Injection and 3 month follow-up appointment following 3rd injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, ultrasound, sonography, injection