Clinical trial NCT01026909: Intraarticular Corticosteroid Therapy in Perthes Disease.
Official title: Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Legg-Calve Perthes Disease
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2009-12-07
Enrollment: 3
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.
Secondary outcomes:
measure: 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.
timeFrame: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Klane K White, MD
role: PRINCIPAL_INVESTIGATOR
References: