Intraarticular Corticosteroid Therapy in Perthes Disease.

Not Applicable

Terminated

• Conditions: Legg-Calve Perthes Disease
• Interventions: Drug: Aristospan 20mg

• Registration Number: NCT01026909
• Lead Sponsor: Seattle Children's Hospital

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

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-07
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Results First Submitted: 2014-11-22
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-22
• Last Update Submitted: 2015-12-22
• Results First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• age of 4 to 12 years
• diagnosed with Idiopathic osteonecrosis of the femoral head
• symptoms less than 12 months old.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection	Aristospan 20mg	Patients in this arm receive one single dose of Triamcinolone hexacetonide injectable suspension (Aristopan), USP, 20mg/mL Parenteral. They will aso be enrolled in physical therapy.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States