Intraarticular Corticosteroid Therapy in Perthes Disease.

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
Klane White, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01026909
First received: October 6, 2009
Last updated: December 22, 2015
Last verified: December 2015
  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. 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.

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 12 Months Post Injection. [ Time Frame: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits. ] [ Designated as safety issue: No ]

    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:
  • 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. [ Time Frame: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2009
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Aristospan 20mg
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
No Intervention: Control
Patients will be enrolled in physical therapy

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

Ages Eligible for Study:   4 Years to 13 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026909

Locations
United States, Washington
Seattle Children's Hospital
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

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
Results First Received: November 22, 2014
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
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 July 27, 2016