Multi-center Comparative Study of Operative Vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
研究概览
简要总结
Cast immobilization in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A non-inferiority randomized controlled trial.
详细描述
This is a multicenter, controlled, prospective, randomized non-inferiority study comparing operative treatment to non-operative treatment of over 3 mm dislocated pediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. A total of 120 patients will be randomized in 1:1 ratio to either operative or non-operative treatment. The study will have a parallel non-randomized patient preference arm. Non-operative treatment will be upper limb immobilization with long arm cast for 4 weeks. Operative treatment will be open reduction and internal fixation (ORIF). Data is collected at baseline and at each follow-up up to 2 years. Quick-DASH is used as primary outcome measure. Secondary outcomes are patient reported pain, differences in range of motion, PedsQL Life inventory questionnaire as well as Mayo elbow preformance score.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray
排除标准
- •Ulnar nerve dysfunction
- •Pathological fracture
- •Open fracture
- •Systemic bone disease
- •Concomitant fracture or injury of the same upper limb requiring operative intervention
- •Other disease preventing participation in full follow-up regime or range of motion exercises
研究组 & 干预措施
RCT operative
Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks.
干预措施: Operative treatment (Procedure)
RCT Non-operative
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
干预措施: Long arm cast (Procedure)
Patient preference operative
Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks.
干预措施: Operative treatment (Procedure)
Patient preference non-operative
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
干预措施: Long arm cast (Procedure)
结局指标
主要结局
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
时间窗: 12 months
Minimum value is 0 and maximum 100. Higher value indicates worse function. Statistically significant difference in QuickDASH score is 6.8 (18) at 12 months FU.
次要结局
- Sensation and cold intolerance(12 months)
- Cosmetic Visual Analoque Scale (CVAS)(12 months)
- Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm(12 months)
- Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)(12 months)
- Mayo Elbow Performance Score (MEPS)(12 months)
- Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)(12 months)
- Need for additional procedures (number)(12 months)
- Grip strength (kg) with hand held dynamometer (jamar)(12 months)
研究者
Petra Grahn
Hand Surgeon
Helsinki University Central Hospital