drugset / Trial / NCT01079455

Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip

NCT01079455

Phase 3 Unknown 489 enrolled University Hospital Pellenberg
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee. Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%. Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.

Timeline

Start
2010-05
Primary completion
2012-07
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.125 % Other
Subject Bupivacaine Other / unclassified 2 ml Other
Comparator Corticosterone Small molecule 2 ml Other
Comparator Corticosterone Small molecule 80 mg Other
Subject Hyaluronic Acid Other / unclassified 2 ml Other
Subject Hyaluronic Acid Other / unclassified 40 mg Other

Indications