NCT01026909|TerminatedResultsDMC
Study Stopped
low recruitment
Loading search results
low recruitment
Sponsor study identifier
interventional
3
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
January 2014
Actual (reported)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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 6, 2009
Actual (reported)December 7, 2009
Actual (reported)October 2013
Actual (reported)January 2014
Actual (reported)January 29, 2016
Actual (reported)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.
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.
This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.
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.
StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits
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.
Patients will be enrolled in physical therapy
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Klane K White, MD
Seattle Children's Hospital
3 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2009
First Posted
December 7, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
WOMAC Hip Score in Children and Adolescents With Perthes Disease
Contact the study team to confirm eligibility.
Primary Completion
October 2013
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
January 29, 2016
Results First Posted
January 29, 2016
Record last verified: 2015-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: