Pavlik Harness Treatment Versus Monitoring for Treatment of Graf Type 2b and 2c Hip Developmental Dysplasia of the Hip (DDH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Ultrasound
研究概览
简要总结
Developmental Dysplasia of the Hip (DDH) is thoroughly manageable if treated correctly. While the standard treatment is using a Pavlik harness, there is not enough research regarding those patients who have stable but immature Graf type 2b and 2c hips and whether a harness is needed.
At Maidstone and Tunbridge Wells NHS Trust, all babies who present with Graf type 2b and 2c hip dysplasia are treated using a Pavlik harness, which is worn 24 hours a day for up to 12 weeks. Although the harness is usually very comfortable, it can result in stress and anxiety for parents, and may make caregiving activities such as bathing, feeding and carrying more difficult.
Our aim is to run a feasibility trial, recruiting babies with type 2b and 2c hip dysplasia, to determine whether there is any difference in a group which is treated with Pavlik harnessing, or whether these hips do in fact mature on their own. We would like to ensure that Pavlik harness treatment is indeed necessary in these groups.
Babies randomised to the comparator group with type 2b and 2c hips would be treated using a Pavlik Harness and following the usual protocol with ultrasound scans at 3 weeks, 8 weeks and 12 weeks post start of treatment, and harness duration is determined by the scan at 8 weeks.
Babies randomised to the Intervention group would be monitored via ultrasound scans at 3 weeks, 6 weeks, 8 weeks and 12 weeks post diagnosis, and should it be determined that their hips are not maturing spontaneously, they will be placed in a harness immediately, and follow the treatment-group protocol. Since the scans are done so frequently, and their hips are stable, there is no risk to these babies.
Babies in both groups would have x-rays at 9 months and 15 months to determine longer-term outcome.
The trial will last for 15 months after diagnosis for each patient, and the end-point of the study would be on achieving a 15-month x-ray for the last recruited patient.
Patients will be informed of the results of the study.
详细描述
Developmental dysplasia of the hip (DDH) is a common cause of childhood disability, and diagnosis after 3 months may lead to the need for surgery and long-term complications. The incidence in the UK before ultrasound (US) screening became available was 1-2 per 1000. Since the advent of selective US screening, estimates in the UK incidence range from 5-30 per 1000. In terms of criteria for screening, there is consensus that a family history of DDH, female gender, breech presentation, primiparity and oligohydramnios increase the risk of DDH, although screening criteria vary amongst centres. There is a lack of evidence to support birth weight, prematurity, multiple pregnancy, mode of delivery or the presence of foot deformity as increased risk-factors for DDH.
Radiographic depiction of the hip is difficult in the first few months of life, due to the absence of the ossific nucleus. The advent of ultrasound (US) has significantly impacted these challenges, and this method has become popular since the first paper describing it by Graf in 1980. The Graf method has been accepted as the Gold Standard in Ultrasound analysis.
Differences in image acquisition and interobserver variation can significantly influence the diagnosis in the border zones between the different categories of the classifications. Reviews conclude that diagnosis by US is 'highly sensitive but poorly specific', and it is not clear how much unnecessary treatment is instituted due to the lack of a benchmark for diagnosis. It is unclear in well centered, stable hip dysplasia, whether treatment alters the natural history of the development of the hip. Randomised trials of abduction treatment of dysplastic hips according to the existing classification systems have failed to show a difference between the treatment and non-treatment groups between six weeks and three months, and between three months and six months .
While low risk, the Pavlik harness is not entirely benign. The rate of avascular necrosis (AVN) varies widely according to application , and has been associated with a longer duration of treatment.
While other complications from a correctly applied harness are rare, it may cause skin crease dermatitis and femoral nerve palsy (which has been linked with treatment failure). It is therefore beneficial to keep time spent in a harness to a minimum, and initiate treatment only when necessary.
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
- None
入排标准
- 年龄范围
- 0 Weeks 至 16 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants from birth to 16 weeks with Graf type 2b or 2c hip dysplasia on ultrasound
排除标准
- •associated neuromuscular, genetic or neurological condition which may complicate the course of treatment
- •babies who have unstable hips on clinical examination
结局指标
主要结局
Ultrasound
时间窗: 12 weeks after initial scan
Alpha angle of 60 degrees needs to be obtained using the Graf classification in order to denote a normal hip
Ultrasound
时间窗: 12 weeks after baseline scan
An alpha angle of 60 degrees using Graf Classification needs to be obtained to denote a normal hip
次要结局
- Parenting Stress Index(3 weeks after baseline scan)
- X Ray(9 months and 15 months of age)
研究者
Nicole Hilburn
Senior Lecturer
Canterbury Christ Church University
