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临床试验/NCT01644344
NCT01644344已完成3 期

Pilot Study for a Randomized Control Trial Comparing the Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Fractures With Stable Internal Fixation Treated at Health Sciences Centre

University of Manitoba2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
39
试验地点
2
主要终点
cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures

研究概览

简要总结

The standard post-operative radiographic protocol for the monitoring of fractures at HSC includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.

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
Single (Care Provider)

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Femur fracture treated with intramedullary nailing
  • Tibia fracture treated with intramedullary nailing
  • Ankle fractures treated with standard compression technique
  • Humeral shaft fractures treated with standard compression technique
  • Forearm fractures treated with standard compression technique
  • One or both bones fractured
  • Simple fracture or presence of single butterfly fragment treated with lag screw
  • Clavicle fracture treated with standard compression technique
  • Olecranon fracture treated with standard compression technique

排除标准

  • Age < 17 years, or open growth plates
  • Multiple orthopaedic fractures
  • History of radiographic appearance of osteoporosis or osteopenia or poor operative bone quality
  • Likely difficult with follow-up in first 6 weeks
  • Same day surgery case
  • Surgeon feels patient should be excluded

结局指标

主要结局

cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures

时间窗: post-operative day one or two in hospital, as well as in clinic at two and six weeks

Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patient in clinic.

次要结局

  • Patient satisfaction(At six weeks post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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