Ultrasound Guided Knee Injections in Musculoskeletal Medicine (PRISMM)

August 4, 2022 updated by: Andrews Research & Education Foundation

Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Joint Line Ultrasound
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
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
Sham Comparator: Joint Line Landmark
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
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
Active Comparator: Suprapatellar Ultrasound Guided
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
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
Sham Comparator: Suprapatellar Landmark
Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.
Procedure: Suprapatellar Landmark
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
3 month follow-up appointment following 3rd injection
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.
Pre-Injection and 3 month follow-up appointment following 3rd injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

American Medical Society for Sports Medicine (AMSSM)

Investigators

  • Principal Investigator: Joshua Hackel, MD, Andrews Institute for Orthopaedic & Sports Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2011

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 24, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRISMM-Knee

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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