Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Bone healing condition
研究概览
简要总结
The purpose of this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture.
详细描述
Acetabular fractures were very common in high-energy injury, because of the anatomic of acetabular was in deep location and the complex form cause the diagnosis and treatment was difficult. For most of displaced acetabular fractures, the preferred treatment is open reduction and internal fixation. The purpose of surgery is to restore acetabular integrity and stability, allow early exercise, decrease complication. Acetabular posterior wall fractures were the most common, the current clinical application fixation of acetabular fractures were common plate and reconstruction steel plate. But when the acetabular posterior wall was fracture, some patients were not satisfied after surgery. The reason is mainly because the reconstruction plate need remoulding in surgery, and it not only led to the extension of operation time, but also cause poor attach. Otherwise, the reconstruction plate need location the angle of screw in surgery. If the operator lack of experience will make into the harm surrounding vessels and nerves. Some research has achieved the improvement from the anatomy of acetabular fractures in the locking plate. But there is not any plate match with the anatomy of the acetabular posterior wall.
This anatomical bone plate was designed base on before plate and had patent protection which is used in clinical trial. It was a new type of internal fixation of acetabular posterior wall fracture, this plate improve the shortcomings of existing technology, provides a pre-formed anatomical fixation plate , the direction of the locking screw holes. This design provide a better attach of acetabular posterior wall, more safe use the screw, making more stable and reliable fixation. This fixation plate was not only suitable for an experienced doctor, but also suitable for a less experienced doctors in theory. They can quickly and accurately fixed in its correct position, thus this fixation plate have advantages of improve surgical success rates, shorter hospital stay, reduce disease painful and it can used in all adult patients.
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women aged 18 years and older (with no upper age limit).
- •Fracture of the acetabular posterior wall fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- •Operative treatment of fractures within 14 days of presenting to the emergency room.
- •Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- •Anticipated medical optimalization for operation.
- •Provision of informed consent by patient or legal guardian.
- •No other major trauma.
排除标准
- •Refuse to participate.
- •Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- •Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- •Retained hardware around the affected acetabular.
- •Infection around the acetabular (i.e., soft tissue or bone).
- •Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
- •Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- •Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- •Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
结局指标
主要结局
Bone healing condition
时间窗: six months
Bone healing condition was checked by radiological examination.
次要结局
- Complications(one year)
- Patient quality of life(one year)
- Rates of revision surgery(one year)
研究者
Peifu Tang
Chief, Professor
Chinese PLA General Hospital
