Intraarticular Corticosteroid Therapy in Perthes Disease. - Full Text View

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:

Genetics Home Reference related topics: Legg-Calvé-Perthes disease

MedlinePlus related topics: Steroids

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

Genetic and Rare Diseases Information Center resources: Legg-Calve-Perthes Disease

U.S. FDA Resources

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 September 30, 2016