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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Kyphoplasty | Experimental | 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. |
|
| Kyphoplasty with Rotary Cutter | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Kyphoplasty | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Min Li | Recruiting | Jinan | Shandong | 250031 | China |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D050815 | Fractures, Compression |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D058498 | Kyphoplasty |
| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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|
| Kyphoplasty with Rotary Cutter | Device | 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. |
|
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| 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 |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |