Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Long term presence of knee pain
研究概览
简要总结
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.
详细描述
Suprapatellar nailing...
Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.
Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.
Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:
- To evaluate the long term presence of knee pain
- To evaluate the long term functional outcomes
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
- •Isolated, unilateral tibial shaft fractures
- •Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
- •age 18-65, including pregnant women
- •open or closed fractures
- •able to sign consent
- •english speaking
排除标准
- •compartment syndrome
- •other lower extremity injuries that will affect functional outcomes
- •problems maintaining follow up (homeless, not willing to return for follow up)
- •pathological fractures
- •prisoners
- •previous retained hardware in the injured leg
- •injuries requiring vascular repair
结局指标
主要结局
Long term presence of knee pain
时间窗: 10 years
During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain.
次要结局
- Knee Range of Motion (ROM)(10 years)
- Fracture Healing(10 years)
- Long term functional outcomes(10 years)