Management of Type 1 Supracondylar Humeral Fractures: a Multicentre Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Faces Pain Scale - Revised (FPS-R)
研究概览
简要总结
This study compares the clinical outcomes of treating pediatric Type 1 supracondylar fracture with a long arm soft cast and no clinical or radiographic follow-up versus the standard treatment in a long arm cast with clinical follow-up.
This is the first multicenter randomized control trial looking at the clinical effectiveness, safety and parental satisfaction of managing inherently stable Type I supracondylar fractures without clinical or radiological follow-up. If found to be safe; children can be managed effectively without in-person follow-up, freeing clinic appointments to children on the waiting list and in these COVID times avoiding unnecessary contacts.
详细描述
PURPOSE The purpose of this study is to compare the clinical outcomes and parental satisfaction of treating pediatric Type I supracondylar fractures with a long arm soft cast and no clinical or radiographic follow-up versus standard treatment in a long arm cast with clinical follow-up.
HYPOTHESIS We propose that with clear instructions given to parents in the form of a clinical consultation at soft cast application and written instructions, a Type I supracondylar fracture can be managed with no significant change in pain, without formal in-person clinic consultation, that the treatment will proceed without any negative consequences and the treatment will be met with high parent satisfaction.
JUSTIFICATION The limiting of unnecessary patient visits, X-rays and interactions has taken on a new importance with the ongoing COVID-19 pandemic. Any research that can limit unnecessary risk to our patients, parents and families in terms of contacts should be considered and implemented now more than ever.
OBJECTIVES Our objective is to determine whether Type I supracondylar fractures can be managed safely and effectively without clinical and radiographic follow-up x-rays.
With the COVID-19 pandemic, there has been an increased need to minimize patient interactions for the safety of patients and healthcare workers alike. Typically, these fractures can be managed with minimal intervention. A cast is applied primarily to alleviate pain and the child is required to return to the hospital to have the cast removed.
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
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced).
排除标准
- •Children diagnosed with a Type II or III supracondylar fracture or any other elbow injury
- •Children who present with neurovascular compromise associated with their fracture
- •Children who have been previously diagnosed with a metabolic or structural bone disease that predisposes them to fractures
- •Diagnostic criteria for a Type I supracondylar fracture will include either:
- •A) A clear fracture line through the supracondylar region with no displacement or angulation of the distal humerus (including a normal anterior humeral line that intersects the capitellum) OR B) The absence of a clear fracture line but history of an extension injury to the arm AND tenderness at the elbow AND local swelling AND presence of a posterior fat pad on plain radiographs.
研究组 & 干预措施
Group 1 "Long-arm full cast and routine follow-up"
Patients assigned to Group 1 will be placed in a long arm cast, at 90-100 degrees in neutral rotation. A referral will then be made to the orthopedic department and the patient reviewed at week 3 with cast removal, clinical assessment and radiographic assessment as determined by the normal practice at the local center.
干预措施: Long arm full cast (Procedure)
Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"
Patients assigned to group 2 will be placed in a long arm cast at 90-100 degrees in neutral rotation. They will be given verbal and written information on the injury, when and how to remove the cast and contact details if there are any concerns.
Since they will not be attending clinical follow-up, an email or telephone survey will be undertaken at 3 weeks and after 6 months. The survey will inquire initially about pain, unplanned returns to the Family Physician and hospital, complications, parent/patient satisfaction and a standardized patient reported outcome score will be taken. Please see attached documentation for the itemized survey questions. The 6 month follow-up will include photographs and an illustrated guide will be given to the families on how to obtain pictures of maximal flexion, extension and the child's carrying angle (attached). Measurements of range of motion from photographs are considered comparable to clinical assessment of range of motion
干预措施: Long arm soft cast (Procedure)
结局指标
主要结局
Faces Pain Scale - Revised (FPS-R)
时间窗: 3 weeks post fracture
The Faces Pain Scale - Revised (FPS-R) will be used to measure pain score. The scale uses a 0 to 10 metric that is in close linear relationship with a visual analogue pain scale. 0 is no pain and 10 is very much pain.
次要结局
- Number of unplanned visits to the hospital or family physician(During cast treatment)
- Is parental satisfaction higher when they are empowered to remove a splint at home and follow a physician directed treatment program?(3 Weeks post fracture)
- Is there a difference in range of elbow joint motion between the two groups at 6 months post fracture?(6 months post fracture)
- • Is the difference in carrying angle from the contralateral arm at 6 months post fracture similar in children undergoing no clinical follow up or radiographic follow up compared to children undergoing routine follow-up as per the standard of care?(6 months post fracture)
研究者
Anthony Cooper
Clinical Associate Professor
University of British Columbia