Intraarticular Corticosteroid Therapy in Perthes Disease.
|ClinicalTrials.gov Identifier: NCT01026909|
Recruitment Status : Terminated (low recruitment)
First Posted : December 7, 2009
Results First Posted : January 29, 2016
Last Update Posted : January 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Legg-Calve Perthes Disease||Drug: Aristospan 20mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2014|
Patients in this arm receive one single dose of Triamcinolone hexacetonide injectable suspension (Aristopan), USP, 20mg/mL Parenteral. They will aso be enrolled in physical therapy.
Drug: Aristospan 20mg
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
No Intervention: Control
Patients will be enrolled in physical therapy
- 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 12 Months Post Injection. [ Time Frame: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits. ]
The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:
Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.
We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales.
- Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day 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 4 weeks, 4 months and 12 months follow up visits ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026909
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Klane K White, MD||Seattle Children's Hospital|