Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
研究概览
简要总结
This is a randomised prospective comparison study to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw for improvement of the implant stability integration and bone healing.
详细描述
Transtrochanteric fractures are a frequent entity, mainly in patients over 65 years old, with low bone density. Most of these fractures of the proximal femur are treated effectively with internal fixation with dynamic hip screw (DHS), nonetheless a conditional factor in the treatment success its in the fracture stability and in the osteoporosis severity.
There is controversy in the treatment decision in patients with osteoporosis and an unstable fracture added the risk of peri-prosthetic infection or increased bleeding during surgery means that the decision to place a DHS versus a prosthesis is debated.
This study represents the first comparison of closed reduction and internal fixation with DHS using calcium sulfate graft versus conventional DHS procedure.
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 (Participant)
盲法说明
The procedure was elected by participant randomization.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 65 and 80 years old
- •Patients classified as 31A1.3 and all 31A2 by the Orthopaedic Trauma Association classification system.
排除标准
- •Patients with stable hip fractures
- •Participants who do not accept the randomization process
- •patients who do not complete follow-up during the study
结局指标
主要结局
Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
时间窗: 12 weeks for each patient
The aim of this study is to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw to improve implant integration and bone healing.
次要结局
未报告次要终点
研究者
Julio Carlos Velez de Lachica
Md. High Specialty Associate Professor of the Joint Surgery Course
Hospital Regional Tlalnepantla