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临床试验/NCT03682328
NCT03682328Unknown不适用

Comparetive Study Between Vertebroplasty and Kyphoplasty in the Management of Osteoporotic Vertebral Body Fractures.

Assiut University0 个研究点目标入组 23 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
23
主要终点
back pain

研究概览

简要总结

Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance.

Surgery is indicated in patients with vertebral body fracture, and concurrent spinal instability or neurologic deficit. The cornerstone of management for vertebral body fractures without neurological impairment is medical therapy, which include analgesics, bed rest, orthoses and rehabilitation. In the majority of patients such treatment modalities are effective. However, conservative management measures are not indicated for every type of fracture. For example, in older patients with vertebral fractures and cardio-respiratory disease it is not possible to prescribe bedrest for long period. Moreover, sometimes anti-inflammatory drugs are poorly tolerated by older patients, and bed rest can lead to further demineralization of the vertebrae, predisposing to future fractures.

Percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body are a useful tool for the management of symptomatic fractures without neurological impairment when conventional measures of treatment can not be adopted. Two different percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body for the management of symptomatic vertebral body fractures without neurological impairment have been developed, namely vertebroplasty and kyphoplasty.

Kyphoplasty and vertebroplasty have gained wide acceptance worldwide to manage patients without neurological impairment suffering from unmanageable pain caused by vertebral body fractures. Both procedures depend on mechanical stabilization of the fracture produced by cement injection into the fractured vertebral body.

Cement augmentation of the vertebral body by vertebroplasty and kyphoplasty was originally introduced for osteoporotic compression fractures, but surgeons have now applied these techniques as a method of enhancing anterior column support while avoiding the morbidity and complications associated with anterior approaches.

The mainstay of the controversy between kyphoplasty and vertebroplasty are height restoration, whether or not this height restoration is clinically significant, and the risks related to height restoration.

详细描述

This study is a Randomized interventional study to be done at neurosurgery department, Assiut Universitu Hospital, Assiut university, Egypt.

  1. Vertebroplasty To achieve a low complication rate, the most important factor which influences the result of the vertebroplasty is the visualization of needle placement and cement application. Vertebroplasty may be performed using both fluoroscopy, and CT scanning to obtain an accurate visualization of needle position and cement distribution. The monitoring of the distribution of the cement under direct fluoroscopic control is another crucial aspect of the procedure, independently from the technique used for needle placement.

Vertebroplasty can be performed under local anaesthesia or a combination of conscious sedation in most patients, and is therefore particularly useful in patients with risk factors for general anaesthesia. General anaesthesia is required only in patients unable to cooperate due to pain or in very agitated patients.

The access path depends on the level of the vertebral segment to be injected. In the lumbar spine, a transpedicular route is preferred. In the thoracic vertebrae, an intercostovertebral access is recommended. In the cervical vertebrae, an anterolateral approach is used.

The cement should be injected while in its tooth-paste like phase to minimize complications from extravasation in the surrounding tissues, as the flow characteristics of the cement change over the time.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: > 60 years.
  • Sex: both males and females.
  • Compressive and burst vertebral body fractures without any neurological deficit.
  • Failure of medical treatment for at least 3-4 weeks

排除标准

  • Unmanageable bleeding disorder.
  • Improvement of the symptoms of the patient with conservative management.
  • Asymptomatic vertebral body fracture or presence of neurological deficit.
  • Local or generalized infection.
  • Known allergy to bone cement.

研究组 & 干预措施

vertebroplasty

Active Comparator

Patients will be managed by equipment of vertebroplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA).

干预措施: vertebroplasty (Procedure)

kyphoplasty

Active Comparator

Patients will be managed by equipment of kyphoplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA).

干预措施: kyphoplaty (Procedure)

结局指标

主要结局

back pain

时间窗: up to 6 months

Measuring and comparing the post-operative back pain via Visual analogue scales system

次要结局

  • kyphotic deformity(up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud M. Gamal

Assistant Lecturer

Assiut University

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