Trial Outcomes & Findings for Intraarticular Corticosteroid Therapy in Perthes Disease. (NCT NCT01026909)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.

Results posted on

2016-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Injection Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.	Control Observation
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraarticular Corticosteroid Therapy in Perthes Disease.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injection n=1 Participants Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.	Control n=2 Participants observation	Total n=3 Participants Total of all reporting groups
Age, Continuous	9 years STANDARD_DEVIATION 0 • n=5 Participants	7.33 years STANDARD_DEVIATION 2.08 • n=7 Participants	7.33 years STANDARD_DEVIATION 2.08 • n=5 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Injection n=1 Participants Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.	Control n=2 Participants Observation
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. After Treatment (12 months) Global Functioning Sca	97 units on a scale	97.5 units on a scale Standard Deviation 3.53
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. Before treatment - Global Functioning Scale	64 units on a scale	79 units on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits

Outcome measures

Outcome measures
Measure	Injection n=1 Participants Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.	Control n=2 Participants Observation
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. Baseline- Average Number of steps per day	6287 steps/day	1448.04 steps/day Standard Deviation 1873.78
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. 4 weeks Follow Up- Average Number of steps per d	1782.19 steps/day	2521.91 steps/day Standard Deviation 1046.12
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. 4 months follow up- average # of steps per day	6985.89 steps/day	2687.57 steps/day Standard Deviation 1999.4
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. 12 months follow up- average # of steps per day	6990 steps/day	2158.7 steps/day Standard Deviation 865.9

Adverse Events

Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Klane White

Seattle Children's Hospital

Phone: 206-987-5678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place