Ultrasound Guided vs Unguided Intra-articular Knee Injections
Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
Studietype
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Exclusion Criteria
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
- History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
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Use of ultrasound machine guidance for accurate needle placement into the knee joint
Andere namen:
|
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Actieve vergelijker: Unguided Injection
Needle placement performed without ultrasound machine guidance
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Needle placement will take place without ultrasound machine guidance
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Accuracy of the initial needle placement into the knee joint.
Tijdsspanne: During the initial needle placement, which can take 1-5 minutes
|
The number of participants with accurate initial needle placement into the knee joint
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During the initial needle placement, which can take 1-5 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
Tijdsspanne: 30 minutes post injection
|
Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't
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30 minutes post injection
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Detection of knee effusions
Tijdsspanne: During procedure, which can take up to 30 minutes to complete
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Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically
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During procedure, which can take up to 30 minutes to complete
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Matthew Pingree, MD, Mayo Clinic
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13-008328
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