Intraarticular Corticosteroid Therapy in Perthes Disease.

This study is currently recruiting participants.
Verified December 2012 by Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Klane White, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01026909
First received: October 6, 2009
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Legg-Calve Perthes Disease
Drug: Aristospan 20mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Injection Drug: Aristospan 20mg
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026909

Contacts
Contact: Klane K White, MD 206-987-5678 klane.white@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Klane K White, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Klane White, Assitant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01026909     History of Changes
Other Study ID Numbers: AEF-24812
Study First Received: October 6, 2009
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Legg-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014