Intraarticular Corticosteroid Therapy in Perthes Disease.

NCT ID: NCT01026909

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-01-31

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

Conditions

Legg-Calve Perthes Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Injection

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.

Group Type: EXPERIMENTAL

Aristospan 20mg

Intervention Type: DRUG

Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.

Control

Patients will be enrolled in physical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aristospan 20mg

Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Klane White

Assitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klane K White, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Other Identifiers

AEF-24812

Identifier Type: -

Identifier Source: org_study_id