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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
Sponsor:
Information provided by (Responsible Party):
Klane White, Seattle Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Legg-Calve Perthes Disease
Intervention Drug: Aristospan 20mg
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Injection Control
Hide Arm/Group Description Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose. Observation
Period Title: Overall Study
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Injection Control Total
Hide Arm/Group Description Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose. observation Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 3 participants
9  (0) 7.33  (2.08) 7.33  (2.08)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
1
 100.0%
2
 100.0%
3
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
0
   0.0%
1
  33.3%
Male
0
   0.0%
2
 100.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
1.Primary Outcome
Title 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.
Hide Description

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.

Time Frame This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injection Control
Hide Arm/Group Description:
Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Observation
Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
After Treatment (12 months) Global Functioning Sca 97 97.5  (3.53)
Before treatment - Global Functioning Scale 64 79  (2.83)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injection Control
Hide Arm/Group Description:
Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Observation
Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: steps/day
Baseline- Average Number of steps per day 6287 1448.04  (1873.78)
4 weeks Follow Up- Average Number of steps per d 1782.19 2521.91  (1046.12)
4 months follow up- average # of steps per day 6985.89 2687.57  (1999.4)
12 months follow up- average # of steps per day 6990 2158.7  (865.9)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Injection Control
Hide Arm/Group Description Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose. Observation
All-Cause Mortality
Injection Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Injection Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Injection Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Klane White
Organization: Seattle Children's Hospital
Phone: 206-987-5678
Responsible Party: Klane White, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01026909     History of Changes
Other Study ID Numbers: AEF-24812
First Submitted: October 6, 2009
First Posted: December 7, 2009
Results First Submitted: November 22, 2014
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016