Legg-Calve Perthes Disease Clinical Trial
Official title:
Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.
| Verified date | December 2015 |
| Source | Seattle Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | January 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 13 Years |
| Eligibility |
Inclusion Criteria: - age of 4 to 12 years - diagnosed with Idiopathic osteonecrosis of the femoral head - symptoms less than 12 months old. Exclusion Criteria: - Symptoms for more than 12 months - Previous treatment other than anti-inflammatories, crutches or bed rest - Subjects more than 8 years old or have a hand bone age greater than 6 years old and lateral pillar B or B/C disease. - Bilateral hip disease - Personal or family history of problems with general anesthesia - Prior steroid treatment - Previous diagnosis of: - Asthma - Identifiable rheumatologic condition - Metabolic Diseases (including but not limited to Gaucher's disease or congenital hypothyroidism) - Sickle cell disease - Known pain syndrome - Hip sepsis - Prior malignancy (solid organ or bone marrow transplant) - Blood Clotting disorder |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Seattle Children's Hospital | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Seattle Children's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Secondary | 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 | No |