GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Treatment failure
研究概览
简要总结
In recent literature, the potential of guided growth of the proximal femur to modify hip growth in patients with cerebral palsy has been shown. Using medial hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to reduce further hip migration and the need for more invasive surgical treatment modalities. Further research is necessary to assess if the results of TMH-PF in combination with adductor tenotomies are significantly better than the results of the current standard of care; adductor tenotomies alone.
The investigators objective is to determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.
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
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spastic CP
- •GMFCS level IV-V
- •Aged 2-8 years
- •At least one hip with an abduction in flexion ≤ 40 degrees
- •Migration percentage of 30-50%
- •Head shaft angle > 145
排除标准
- •Not fit for surgery
- •History of bony hip surgery to the affected hip
- •Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index > 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs
结局指标
主要结局
Treatment failure
时间窗: from enrollment to the end of study (8 years)
The Primary study outcome is treatment failure, defined as: * Need for secondary bony hip surgery to the affected hip or progression to hip migration \> 50% at 5-year follow-up . An indication for secondary bony surgery will be defined as; * Migration percentage \> 50% at a minimum of 1 year after surgery, OR * An increased migration \> 10% in 1 year during follow-up * Increase in Acetabular index to \> 30 degrees or an increase of more than 5 degrees during follow-up
次要结局
- Radiographic parameters(from enrollment to the end of study (8 years))
- 3-dimensional shape analysis of proximal femur(directly postoperative, at 2-year follow-up and at 5-year follow-up)
- CPChild questionnaire(from enrollment to the end of study (8 years))
- CPG questionnaire(from enrollment to the end of study (8 years))
- Secondary surgical interventions other than bony procedure(from enrollment to the end of study (8 years))
研究者
Merel Roelen
MD, PhD candidate
Erasmus Medical Center