Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 7
- 主要终点
- The primary outcome of this study is the Disability of Arm, Shoulder and Hand (DASH) score.
研究概览
简要总结
The subject's broken humerus (arm) is suitable for treatment with a fracture brace or operative fixation with plate and screws. Both of these types of treatments are often used by doctors to fix broken bones. If the subject agrees to participate in this study, the subject will be assigned by the treating surgeon to one of the following groups:
Group B: Non-operative treatment with a fracture brace Group P: a plate & screws - a metal device placed on top of the bone.
The investigators will collect information about the subject's arm fracture as it is treated with examinations and X-rays. X-rays will be obtained often in the first several months, depending on how the fracture is healing. This is determined by the doctor and will not be determined by the subject's participation in this research study.
Both treatments are routinely used and this study hopes to provide information regarding each type of treatment on the subject's functional outcome. A subject's treatment will not be affected whether they choose to participate in this research study or not.
The treatment of these subjects is no different because of this study. The treating surgeon will discuss with the patient their preferred treatment for the isolated humeral shaft fracture. If they meet the inclusion/exclusion criteria, they will be approached for participation in one of two treatment groups depending on a previous decision by the patient and the treating surgeon.
Hypotheses:
- Patients with an isolated humeral shaft fracture that are plated will have a more rapid return to ADL's, work and full functional capacity than patients treated conservatively.
- Patients treated with plate technique will have a more rapid improvement in functional outcome scores, decreased pain scores and patient satisfaction than those managed conservatively.
- Complication rates of infection and iatrogenic neurologic injury will be higher in patients treated operatively.
- Nonunion and malunion will be higher in patients managed conservatively.
详细描述
A. Rationale Humeral shaft fractures (OTA 12A, B or C) are not uncommon injuries and have been long considered fractures, which respond well to conservative (or nonoperative) management. Since Bohler's (1964) statement that humeral shaft fractures are "the most benign of all fractures of the long bones", many additional peer-reviewed publications have concluded that conservative management of this injury, in isolation, produces an excellent and uncomplicated result. Sarmiento's work resulted in a treatment algorithm utilizing functional bracing which remains the accepted standard of care for isolated humeral shaft fractures. Much of the early work on operative treatment of this injury reflected results, often poor, obtained when utilizing early generation implants and surgical techniques. In addition, a number of studies have reported the results of humeral shaft fractures managed with intramedullary nails. Although controversy remains, we believe the publications of McCormack, et.al.1 and Chapman, et.al.2 have concluded in a prospective randomized comparison fashion that plating now produces a superior outcome to intramedullary nailing in humeral shaft fractures. Very few existing publications3-7 compare conservative versus operative treatment of humeral shaft fractures. Of these, only one (Nast-Kolb, et.al.3) does so in a prospective manner. Even this study included patients with various associated and possibly confounding injuries and treatment selection was not controlled or randomized in any way.
No study has ever compared the results of isolated humeral shaft fractures treated conservatively/nonoperatively versus operatively in a prospective cohort comparison. In addition, few studies of humeral shaft fractures have utilized any form of validated functional outcome measures when drawing conclusions about given treatment options.
B. Hypothesis or Objective The objective of this study is to determine whether isolated humeral shaft fractures are optimally treated with internal fixation or bracing.
Specific Aim #1 To determine the healing rates between operative and non operative management in a prospective study.
Hypothesis 1. Nonunion and malunion will be higher in patients managed conservatively.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a closed, humeral shaft fracture
- •English Speaking
- •Age between 18-65 at the time of injury
- •Entry into the study within 2 weeks of injury
- •Available for follow-up for at least 12 months
- •Patient signs informed consent
排除标准
- •Age less than 18 or greater than 65 at time of injury
- •Patients who are skeletally immature
- •Humeral shaft fractures that extend into the articular surface
- •Open humeral shaft fractures
- •Additional long bone injuries of upper or lower extremity that would compromise outcome assessment
- •Vascular injury requiring repair
- •Pathologic fracture
- •Definitive treatment delay of more than 2 weeks from initial injury
- •Immunocompromised patient
- •Unable to comply with post-operative rehabilitation protocols or instructions
- •Current or impending incarceration
- •Unlikely to follow-up in surgeon's estimation
- •Pregnant or lactating female
- •Previous retained hardware in humeral shaft
结局指标
主要结局
The primary outcome of this study is the Disability of Arm, Shoulder and Hand (DASH) score.
时间窗: Enrollment, 12 Week, 6 Month, and 12 Month Follow-Ups
10 units difference of DASH will be considered as a clinically meaning full difference. Based on previous studies, the standard deviation of DASH is around 20. With 64 subjects in each group (total 128), we will have 80% power to detect a difference in mean of 10 between two study arms assuming the common standard deviation is 20 using a student t-test with type I error rate 0.05.
次要结局
未报告次要终点
研究者
Howard Place, MD
Professor
St. Louis University