Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures: a Cohort Study of 30 Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiographic Union Score (RUS)
研究概览
简要总结
Background
Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.
Methods
The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.
Discussion
This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
- •Fractures need to be complete (not unicortical or green stick)
- •Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction
排除标准
- •We exclude patients
- •with fractures that are well managed conservatively (undisplaced or minimally displaced)
- •with previous ipsilateral forearm fracture
- •with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
- •with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
- •unable to participate in follow-up
- •with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
- •in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)
结局指标
主要结局
Radiographic Union Score (RUS)
时间窗: 3 months
RUS is a score derived from assessing AP and lateral radiographs. Each bone cortex (anterior, posterior, medial and lateral) is assigned a score of 1 to 3. A cortex with a visible fracture line and no callus is given a score of 1, a cortex with callus but a visible fracture line is scored as 2 and a cortex with bridging callus and no visible fracture line is scored as 3. Scores are added to give a minimum score of 4 (definitely not healed) and a maximum of 12 (definitely healed). 12 is best.
次要结局
- Faces Pain Scale - Revised (FPS-R)(3 months)
- Bilateral elbow and forearm range of motion(3 months)
- Visual Analogue Scale (VAS)(3 months)
研究者
Morten Jon Andersen
Consultant Orthopedic Surgeon
Children's Fractures Interest Group, Denmark