Intraarticular Corticosteroid Therapy in Perthes Disease.
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|