Clinical Trial: Intraarticular Corticosteroid Therapy in Perthes Disease.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.
Brief Summary: 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.
Detailed Summary: 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. The cause of LCP is still unknown, but tends to occur predominantly in boys from ages 4-12. For the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. 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. The investigators will test for improved outcomes by measuring functional outcomes (PODCI and ASKp questionnaires, StepWatch activity monitor), hip range of motion and visual-analog pain scales. The investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.Additional biological research will be performed. There is no human information on the inflammatory response that occurs in the hip joint of children with Perthes disease, and there are no true animal models of Perthes disease. To better understand the pathobiology of Perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies
Sponsor: Seattle Children's Hospital
Current Primary Outcome: 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.
Original Primary Outcome: 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 36 months post injection. [ Time Frame: This exam is to be administered at time of enrollment and at 4, 12, 24 and 36 months follow up visits. ]
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Second outcome variable: Ambulatory activity. It will be defined as average steps/day and percentage time active 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 at 5 time points after treatment (two weeks and 4, 12, 24 and 36 months follow up visits) ]
Information By: Seattle Children's Hospital
Dates:
Date Received: October 6, 2009
Date Started: March 2009
Date Completion:
Last Updated: December 22, 2015
Last Verified: December 2015
