Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Upper limb function
研究概览
简要总结
Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary.
The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.
详细描述
The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened.
Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will analyze the database without knowing which treatment arm each participant was allocated. He does not work in the center where the study will be carried out, nor does he contact the participants.
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 5 years to 10 years
- •Unilateral metaphyseal distal radius fracture
- •Fracture shortening of 0 to 10mm or angulation of 10 ° to 20 ° in the oblique plane. (AO 23-M 2-3 or 23r-M 2-3)
- •Admission in the first 14 days after the fracture
排除标准
- •Polytrauma: Injury Severity Score (ISS)> 16
- •Associated fracture in the same limb.
- •Neuromuscular pathology (e.g., cerebral palsy, spinal muscular atrophy, Duchenne disease)
- •Open fractures.
- •History of fractures, septic arthritis, or osteomyelitis in the same limb.
- •Neurological or vascular injury in the fractured upper limb.
- •Known alteration of bone metabolism (e.g., osteogenesis imperfecta, rickets, osteopetrosis, skeletal dysplasias, lysosomal storage diseases).
- •Congenital longitudinal deficiency.
结局指标
主要结局
Upper limb function
时间窗: 6 months
Assess upper extremity function with PROMIS Physical Function, Upper Extremity subdomain. The investigators will apply the parent-proxy version between 5 and 7 years old and the pediatric version between 8 and 10.
次要结局
- Deformity(2 weeks, 3 months and 9 months)
- Wrist range of motion(3 and 6 months)
- Ulnar variance(9 months)