Osteoporotic Fracture of Vertebra Clinical Trial
Official title:
Comparetive Study Between Vertebroplasty and Kyphoplasty in the Management of Osteoporotic Vertebral Body Fractures.
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.
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.
Cement injection may be stopped when the anterior two thirds of the vertebral body are
filled and the cement is homogenously distributed between both endplates. During cement
injection, continuous fluoroscopic monitoring is performed to immediately detect
extravasations of cement. In case of extravasation, the procedure must be interrupted.
A direct correlation between the risk of extraosseous extravasation and the amount of
cement injection has been proposed, but, to date, no studies have addressed the specific
issue of the volume of cement needed during vertebroplasty. Normally, 2.5-4 mL of cement
should provide good filling of the vertebra and achieve both consolidation and pain
relief in patients with osteoporotic fractures.
2. Kyphoplasty Kyphoplasty is normally performed under general anaesthesia in some patients
as proper placement of the balloons is mandatory, and several steps need to be taken
before cement can be injected.
A mono- or bilateral trans- or para-pedicular approach is used to insert a working cannula
into the posterior aspect of the vertebral body. The procedure is performed under fluoroscopy
or CT scan control. With reaming tools, two working channels within the anterior aspect of
the vertebral body are produced, and the appropriate balloon is inserted. To reduce the
fractured vertebra and to produce a cavity, the balloon is inflated using visual volume and
pressure controls. The behaviour of the vertebral body is monitored under fluoroscopic
control. Inflation is stopped when a pressure above 250 psi is obtained, when the balloon
contacts the cortical surface of the vertebral body, or if the balloon expands beyond the
border of the vertebral body, and if the height of the vertebra is restored. Successively,
the balloons are retracted and cement polymethylmetacrylate (PMMA) is injected using a blunt
cannula under continuous fluoroscopic control.
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