A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient Satisfaction Scores using Pediatric Outcome Questionnaire
研究概览
简要总结
This study looks at treatment for developmental dysplasia of the hip (DDH), a condition where there is abnormal development of a child's hip joint. While spica casts are shown to very effective in treating DDH, and potentially more effective than hip braces alone, other research shows that the outcomes from braces are equivalent to those of spica casts with the added advantage of greater patient satisfaction and less burden on families. Therefore, the 12-week experimental protocol in the study, with the first 6 weeks involving the spica cast and the second 6 weeks the hip brace, was designed to determine if both treatment methods can be combined for an optimal patient experience.
详细描述
The primary objective of this study is to compare the clinical outcomes of patients who undergo closed reduction of a developmentally dysplastic hip and are treated with six weeks of supplemental casting to those treated with twelve weeks of supplemental casting.
The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway (12 weeks of spica casting).
The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress. Following 6 weeks of recovery, the control group will have their spica cast replaced in the operating room, with the child anesthetized, by another cast for 6 weeks. The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks. Participants will be instructed to complete the full 12 weeks of the protocols. Only patients who complete the full length of treatment in either group will be considered for the study. The physicians will keep track of patients during visits to ensure the protocols are being followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Diagnosed with DDH
- •Require closed reduction of the hip and hip spica casting
- •between 6-18 months old
- •Alpha angle <60 degrees, beta angle >55 degrees
- •i. Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is >60 degrees
- •ii. Beta angle is an angle created by lines along the labrum and ilium, normal is <55 degrees
- •c.Have either failed Pavlik harness or have dislocated hip on imaging
排除标准
- •Patients over the age of 18 months
- •Patients with DDH who do not require closed reduction surgery
- •Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
- •Families that do not want to participate in the study
- •Patients with dysplasia that need open reduction
结局指标
主要结局
Patient Satisfaction Scores using Pediatric Outcome Questionnaire
时间窗: 6 weeks and 12 weeks
Pediatric Outcome Questionnaire - 86 questions, item scores are summed for a total score. Total score range from 0-100, Higher score means higher satisfaction.
Hospital Re-Admission Rate
时间窗: up to 12 weeks
Number of participants re-admitted to the hospital
Mean Time to Hospital Re-Admission
时间窗: up to 12 weeks
Mean Time to Hospital Re-Admission in days
Complications Rate
时间窗: up to 12 weeks
The incidence of any complications that occur over the 12 week course.
Re-Dislocation Rate
时间窗: up to 12 weeks
The incidence of DDH re-occurrence in patients over the 12 week course of the casting or bracing for early re-dislocation rate. This will be the main quantitative value that directly measures the effectiveness of the protocols on maintaining the results of the closed reduction surgery.
次要结局
- Family Satisfaction/Burden using Pediatric Outcome Questionnaire(12 weeks)