Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Spine Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Conventional Kyphoplasty

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.

Group Type EXPERIMENTAL

Conventional Kyphoplasty

Intervention Type 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.

Kyphoplasty with Rotary Cutter

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.

Group Type ACTIVE_COMPARATOR

Kyphoplasty with Rotary Cutter

Intervention Type 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.

Interventions

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Conventional Kyphoplasty

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.

Intervention Type DEVICE

Kyphoplasty with Rotary Cutter

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.

Intervention Type DEVICE

Other Intervention Names

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Conventional PKP PKP with Rotary Cutter

Eligibility Criteria

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Inclusion Criteria

1. Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
2. Patient has read and sign the informed consent
3. Male or female, 50 years or older
4. Compressive and burst vertebral body fractures without any neurological deficit.
5. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment

Exclusion Criteria

1. Neurological signs related to the vertebral fracture to treat
2. Unmanageable bleeding disorder
3. History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
4. Known allergy to bone cement
5. Local or generalized infection
6. Improvement of the symptoms of the patient with conservative management

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No