Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
The cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones.
The rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely.
Min Li
Jinan, Shandong, China
RECRUITINGBack pain: Visual analogue scales system
Measuring and comparing the post-operative back pain via Visual analogue scales system
Time frame: up to 2 years
Refracture
Number of new vertebral fractures documented radiologically
Time frame: up to 2 years
Kyphotic angle and global thoracic and lumbar angulations
Time frame: up to 2 years
The patterns of cement opacification
The patterns of cement opacification were classified as solid patterns (cement forms a mass), trabecular patterns (cement spread along the fine bone trabeculae), and mixed patterns (cement forms a mass with spreading along the fine bone trabeculae)
Time frame: during the procedure of PKP
Height of the treated vertebral body
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements
Time frame: Preoperative, up to 2 years
Medico-economic follow-up
Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.
Time frame: up to 2 years
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