Ultrasound Guided vs Unguided Intra-articular Knee Injections
Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
|
Use of ultrasound machine guidance for accurate needle placement into the knee joint
Autres noms:
|
|
Comparateur actif: Unguided Injection
Needle placement performed without ultrasound machine guidance
|
Needle placement will take place without ultrasound machine guidance
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accuracy of the initial needle placement into the knee joint.
Délai: During the initial needle placement, which can take 1-5 minutes
|
The number of participants with accurate initial needle placement into the knee joint
|
During the initial needle placement, which can take 1-5 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
Délai: 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
|
30 minutes post injection
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Detection of knee effusions
Délai: During procedure, which can take up to 30 minutes to complete
|
Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically
|
During procedure, which can take up to 30 minutes to complete
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Matthew Pingree, MD, Mayo Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-008328
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