Range of Ankle and Knee Motion Development After Gastrocsoleus Lengthening in Cerebral Palsy: a Register-based Prospective Cohort Study: Registered Report Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 186
- 主要终点
- Ankle ROM
研究概览
简要总结
The goal of this study is to compare passive ankle and knee range of motion (ROM) development after surgery to the gastrocsoleus complex, in children with cerebral palsy (CP).
The analysis will compare knee and ankle ROM development between types and levels of surgery performed to achieve lengthening of the gastrosoleus complex. Also, associations between treatment outcomes and Gross Motor Classification System level (GMFCS-level) as well as CP-subtype will be evaluated.
This is a retrospective longitudinal study on the effects of gastrocsoleus complex lengthening on ROM development. The study is based on data from the Swedish Surveillance Program for Cerebral Palsy (CPUP)
详细描述
The objective of the current study is to analyze the development of ankle and knee range of motion (ROM) related to type and level of surgery, age at surgery and CP-subtype.
Materials and methods
Scope of the analyses The analysis will compare knee and ankle ROM development between types and levels of surgery performed to achieve lengthening of the gastrosoleus complex. Also, associations between treatment outcomes and GMFCS-level as well as CP-subtype will be evaluated.
Study Objectives To determine which, if any, surgery at muscular level (zone 1 and 2), open surgery at tendinous level (zone 1) and percutaneous surgery at tendinous level (zone1) is more advantageous in terms of subsequent knee and ankle ROM development. We hypothesize that children with BSCP having surgery on the Achilles tendon is more prone to develop exaggerated dorsiflexion in the ankle as well as knee contractures.
Endpoints
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered in CPUP Sweden (Follow up surveillance program for people with verebral palsy), treated with isolated surgical lengthening of the gastrocsoleus complex and born 2000-2011.
排除标准
- •Children treated with other surgical procedures (soft tissue surgery to the foot, leg, knee and hamstrings and osteotomies or arthrodesis to all lower extremity) or where the type of gastrocsoleus lengthening could not be verified, will be excluded from the analysis but described using summary statistics.
结局指标
主要结局
Ankle ROM
时间窗: Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022
Polynomial regression coefficients describing mean ankle ROM development over follow-up time.
次要结局
- Knee ROM(Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022)
- Composite endpoint(Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022)
- Each component endpoint(Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022)
研究者
Olof Lindén
Consultant Paediatric Orthopaedic Surgeon
Region Skane