Skip to main content
Clinical Trials/NCT03293238
NCT03293238CompletedNot Applicable

Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections

Andrews Research & Education Foundation2 sites in 1 country63 target enrollmentStarted: November 3, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
63
Locations
2
Primary Endpoint
Number of Participants With Successful Knee Injection

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Procedural Satisfaction Score at 3 Months Post Injection(3 month follow-up appointment following 3rd injection)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score(Pre-Injection and 3 month follow-up appointment following 3rd injection)

Investigators

Sponsor
Andrews Research & Education Foundation
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials