Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 4 to 12 years
- •diagnosed with Idiopathic osteonecrosis of the femoral head
- •symptoms less than 12 months old.
排除标准
- •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:
- •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
研究组 & 干预措施
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.
干预措施: Aristospan 20mg (Drug)
结局指标
主要结局
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.
时间窗: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.
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.
次要结局
- 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)
研究者
Klane White
Assitant Professor
Seattle Children's Hospital