Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Sponsor

Li Min (Other)

Overall Status

Recruiting

CT.gov ID

NCT03850938

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Fracture	Device: Conventional Kyphoplasty Device: Kyphoplasty with Rotary Cutter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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. Other Names: Conventional PKP
Active Comparator: 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.	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. Other Names: PKP with Rotary Cutter

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Other Names:

Conventional PKP

Active Comparator: 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.

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.

Other Names:

PKP with Rotary Cutter

Outcome Measures

Primary Outcome Measures

Back pain: Visual analogue scales system [up to 2 years]
Measuring and comparing the post-operative back pain via Visual analogue scales system

Secondary Outcome Measures

Refracture [up to 2 years]
Number of new vertebral fractures documented radiologically
Kyphotic angle and global thoracic and lumbar angulations [up to 2 years]
The patterns of cement opacification [during the procedure of PKP]
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)
Height of the treated vertebral body [Preoperative, up to 2 years]
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements
Medico-economic follow-up [up to 2 years]
Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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