Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity
研究概览
简要总结
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
详细描述
This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with > 10° of angulation and/or > 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.
Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7 to12 year old children
- •Open distal radial physis
- •Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
- •More than 10 degrees of angulation
- •with or without less than 10mm of shortening
排除标准
- •Patients with bilateral fractures
- •Gustilo-Anderson grade I-III open fracture
- •Neurovascular deficit
- •Compartment syndrome
- •Pathologic fracture
- •Patient not able to give a written informed consent
研究组 & 干预措施
FIN (Flexible intramedullary nail)
Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.
干预措施: Flexible intramedullary nail (FIN) (Procedure)
Long arm cast
Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.
干预措施: Reduction auder general anesthesia and long arm cast (Procedure)
Patient Choice FIN
Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.
干预措施: Flexible intramedullary nail (FIN) (Procedure)
Patient Choice cast
Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.
干预措施: Reduction auder general anesthesia and long arm cast (Procedure)
结局指标
主要结局
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
时间窗: 12 months
We aim to confirm that 75 percent of FIN patients have a better PROMIS UE score than what the mean score of the cast patients will be assuming both groups have the same standard deviation. PROMIS (Patient-Reported Outcomes Measurement Information System) scores are normalized to a mean score of 50, standard deviation of 10, with a theoretical range of 0 to 100. A higher score corresponds to a greater amount of the domain being measured.
Pro-supination
时间窗: 12 months
Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.
次要结局
- Cosmetic VAS(6 weeks, 3, 6 and 12 months)
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity(6 weeks, 3, 6 months)
- Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)(6 weeks, 3, 6 and 12 months)
- Need for re-interventions(6 weeks, 3, 6 and 12 months)
- Upper limb ROM(6 weeks, 3, 6 months)
- Return to sport/musical instrument and level(6 weeks, 3, 6 and 12 months)
- Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)(6 weeks, 3, 6 and 12 months)
- Quick Disabilities of the Arm, Shoulder and Hand score(6 weeks, 3, 6 and 12 months)
- Rate of participants with malunion(6 weeks, 3, 6 and 12 months)
- Adverse effects(6 weeks, 3, 6 and 12 months)
研究者
Petra Grahn
Hand Surgeon, Principal investigator
Helsinki University Central Hospital