Prospective, Multi-Center Adolescent Clavicle Fracture Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Changes in functional score from time of injury (or from time of surgery) using the American Shoulder and Elbow Surgeons score (ASES)
研究概览
简要总结
Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10-18
- •Diagnosis of a primary diaphyseal clavicle fracture
- •Fracture must be completely displaced
- •Patient - BCH subjects must pursue follow-up at BCH main campus or Waltham must be 59 days or less from the primary fracture
- •All study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of Boston Children's Hospital for long-term follow-up questions (out to the 2-year time point). This can/will be done via phone, mail, text message, and/or email.
排除标准
- •Pathological fracture
- •Previous ipsilateral fracture
- •Unable to fill out outcome collection forms
- •Refusal to participate
- •Underlying neurologic or neurocognitive disorder that affects UE function
- •Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
- •Unable to project injury X-ray films if treated initially at an institution that is not a member of this register
结局指标
主要结局
Changes in functional score from time of injury (or from time of surgery) using the American Shoulder and Elbow Surgeons score (ASES)
时间窗: 2 years
Patient-reported function over time will be assessed using the American Shoulder and Elbow Surgeons score (ASES). The ASES is a composite instrument comprised of two sections, including patient self-reported pain (7 items) and patient self-reported activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
次要结局
- Patient Return-to-Sport after injury (or surgery)(2 years)
- Patient Quality of Life after injury (or surgery) using the EQ-VAS.(2 years)
- Changes in functional score from time of injury (or from time of surgery) using the Disabilities of the Arm, Shoulder, and Hand Score (Quick-DASH).(2 years)
- Patient Quality of Life after injury (or surgery) using the EQ-5D-3L.(2 years)
- Patient Satisfaction with treatment outcome after injury (or surgery)(2 years)
- Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale.(2 years)
研究者
Benton Heyworth
Principal Investigator
Boston Children's Hospital