Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Total number of complications between PFN-A short and PFN-A long
研究概览
简要总结
- Introduction:
Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm). 2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A
Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year.
Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year. 3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 60 years old above.
- •Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
- •Patients that accept to participate on the study under consent
排除标准
- •Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
- •Combination of fractures in the proximal femur.
- •Pathological fractures.
- •Diaphyseal femoral fractures.
- •Rejection of surgery by the patient.
- •Contraindications to the use of either implants studied.
- •Patients who do not wish to participate in this study
研究组 & 干预措施
Standard PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
干预措施: PFN-A (Device)
Long PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)
干预措施: PFN-A (Device)
结局指标
主要结局
Total number of complications between PFN-A short and PFN-A long
时间窗: One year
follow-up data is recruited at 4 weeks, 3 months and one
次要结局
- Complete and uneventful radiological and clinical healing of the fracture and mortality(One year)
研究者
Ferran Fillat Gomà
Medical Doctor
Corporacion Parc Tauli