Intraarticular Corticosteroid Therapy in Perthes Disease.

Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Legg-Calve Perthes Disease
• Intervention / Treatment: Drug: Aristospan 20mg

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Klane K White, MD, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 7, 2009

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Femur Head Necrosis; Osteonecrosis; Legg-Calve-Perthes Disease; Anti-Inflammatory Agents; Triamcinolone hexacetonide
• Other Study ID Numbers: AEF-24812