Intraarticular Corticosteroid Therapy in Perthes Disease.
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. The cause of LCP is still unknown, but tends to occur predominantly in boys from ages 4-12. For the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment. The investigators will test for improved outcomes by measuring functional outcomes (PODCI and ASKp questionnaires, StepWatch activity monitor), hip range of motion and visual-analog pain scales. The investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.Additional biological research will be performed. There is no human information on the inflammatory response that occurs in the hip joint of children with Perthes disease, and there are no true animal models of Perthes disease. To better understand the pathobiology of Perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.|
- Primary outcome variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) will be the primary endpoint as a measure of function and health related quality of life at 36 months post injection. [ Time Frame: This exam is to be administered at time of enrollment and at 4, 12, 24 and 36 months follow up visits. ] [ Designated as safety issue: No ]
- Second outcome variable: Ambulatory activity. It will be defined as average steps/day and percentage time active as measured by the StepWatch Activity Monitor for a 7 day sample. [ Time Frame: StepWatch monitor will be used 7 days prior to treatment and at 5 time points after treatment (two weeks and 4, 12, 24 and 36 months follow up visits) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||January 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Drug: Aristospan 20mg
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026909
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Klane K White, MD||Seattle Children's Hospital|