TREATMENT OF SUPRACONDYLAR FRACTURES IN ADOLESCENTS: CLOSED REDUCTION AND CIRCULAR RING EXTERNAL FIXATION VERSUS OPEN REDUCTION AND INTERNAL FIXATION
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Range of motion (ROM), change is being assessed
研究概览
简要总结
Patients treated with circular external fixation will have better outcomes (as measured by range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and internal fixation (ORIF).
详细描述
The purpose of this study is to compare patients who undergo ORIF versus circular external fixation for supracondylar humerus fractures in children ages 12-18. We are asking parental permission to collect information about their child's injury, x-rays, obtain ROM measures, collect input from questionnaires, and review other medical information relating to the injury.
The study is NOT about randomizing subjects to treatment, rather we are asking permission to keep track of the decisions that are made about our population's treatment and how it impacts their recovery.
The eligibility criteria is subject's between 12 and 18 years, if supracondylar/periarticular humerus fracture needed operative fixation, and the fracture is unable to be treated with percutaneous skeletal fixation. Patients will be excluded if they have had a previous elbow injury, Osteogenesis imperfecta or another fragile bone disease, elbow stiffness from another cause, or any pre-existing arm weakness.
The outcome measures all enrolled subjects will complete are the QuickDASH and the Pediatric and Adolescent Outcomes Instruments (PODCI). The QuickDASH is a shortened version of the DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure which is intended to measure symptoms and functions in people with musculoskeletal disorders of the upper limb. The QuickDASH is valid and reliable and is used for clinical and research purposes. The PODCI is designed to assess patients overall health, pain and ability to participate in normal daily activities in patients under 19 years of age. We will only distribute both questionnaires to the subjects and we are not collecting parent perception.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 and 18 years old
- •Supracondylar/periarticular humerus fracture needed operative fixation
- •Fracture is unable to be treated with percutaneous skeletal fixation.
排除标准
- •Any previous elbow injury
- •Osteogenesis imperfecta or another fragile bone disease
- •Elbow stiffness from another cause
- •Any pre-existing arm weakness.
结局指标
主要结局
Range of motion (ROM), change is being assessed
时间窗: Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years
Assessing ROM (elbow flexion/extension) in the initial post-operative period and long-term follow-up is an important outcome measure since it correlated with the ability to perform certain tasks with the arm (e.g. reaching head to shampoo/brush hair, reaching mouth to eat, etc.) The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.
次要结局
- Treatments, change is being assessed(Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years)
研究者
Jaclyn Hill
Assistant Professor
Baylor College of Medicine