Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures

Conditions
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Spine Fracture

Intervention / Treatment
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* Device: Conventional Kyphoplasty
* Device: Kyphoplasty with Rotary Cutter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure Patient has read and sign the informed consent Male or female, 50 years or older Compressive and burst vertebral body fractures without any neurological deficit. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment Exclusion Criteria: Neurological signs related to the vertebral fracture to treat Unmanageable bleeding disorder History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain. Known allergy to bone cement Local or generalized infection Improvement of the symptoms of the patient with conservative management

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Kyphoplasty<br>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. | Device: Conventional Kyphoplasty<br>* 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.<br>* Other names: Conventional PKP;|
| Active Comparator: Kyphoplasty with Rotary Cutter<br>The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration, which may induce a cavity with barriers pushed by balloon dilatation. Then, the structure of the cavity is destroyed by a rotary cutter. Finally, the cement is injected, which may effectively interdigitates with the healthy cancellous bone. | Device: Kyphoplasty with Rotary Cutter<br>* 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.<br>* Other names: PKP with Rotary Cutter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain: Visual analogue scales system | Measuring and comparing the post-operative back pain via Visual analogue scales system | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refracture | Number of new vertebral fractures documented radiologically | up to 2 years | 
| Kyphotic angle and global thoracic and lumbar angulations |  | 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) | 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 | 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. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractures, compression, back pain, bone cements, kyphoplasty