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Ultrasound Guided Knee Injections in Musculoskeletal Medicine

Not Applicable
Completed
Conditions
Knee Osteoarthritis
Interventions
Procedure: Joint line landmark
Procedure: Suprapatellar Landmark
Procedure: Joint line ultrasound
Procedure: Suprapatellar ultrasound guided
Registration Number
NCT03293238
Lead Sponsor
Andrews Research & Education Foundation
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Joint Line LandmarkJoint line landmarkPatients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.
Suprapatellar LandmarkSuprapatellar LandmarkPatients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.
Joint Line UltrasoundJoint line ultrasoundPatients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.
Suprapatellar Ultrasound GuidedSuprapatellar ultrasound guidedPatients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Successful Knee InjectionProcedure 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 Outcome Measures
NameTimeMethod
Procedural Satisfaction Score at 3 Months Post Injection3 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.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) ScorePre-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.

Trial Locations

Locations (1)

Andrews Research & Education Foundation

🇺🇸

Gulf Breeze, Florida, United States

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