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Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Primary Purpose

Spine Fracture

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional Kyphoplasty
Kyphoplasty with Rotary Cutter
Sponsored by
Li Min
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Fracture focused on measuring fractures, compression, back pain, bone cements, kyphoplasty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Min LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional Kyphoplasty

Kyphoplasty with Rotary Cutter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Back pain: Visual analogue scales system
Measuring and comparing the post-operative back pain via Visual analogue scales system

Secondary Outcome Measures

Refracture
Number of new vertebral fractures documented radiologically
Kyphotic angle and global thoracic and lumbar angulations
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)
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
Medico-economic follow-up
Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.

Full Information

First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Li Min
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1. Study Identification

Unique Protocol Identification Number
NCT03850938
Brief Title
Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures
Official Title
Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Min

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Fracture
Keywords
fractures, compression, back pain, bone cements, kyphoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Kyphoplasty
Arm Type
Experimental
Arm Description
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.
Arm Title
Kyphoplasty with Rotary Cutter
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional Kyphoplasty
Other Intervention Name(s)
Conventional PKP
Intervention Description
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
Intervention Name(s)
Kyphoplasty with Rotary Cutter
Other Intervention Name(s)
PKP with Rotary Cutter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Back pain: Visual analogue scales system
Description
Measuring and comparing the post-operative back pain via Visual analogue scales system
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Refracture
Description
Number of new vertebral fractures documented radiologically
Time Frame
up to 2 years
Title
Kyphotic angle and global thoracic and lumbar angulations
Time Frame
up to 2 years
Title
The patterns of cement opacification
Description
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
Title
Height of the treated vertebral body
Description
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
Title
Medico-economic follow-up
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Min Li
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Li, M.D.
Phone
13953176057
Email
liminyingxiang@163.com

12. IPD Sharing Statement

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Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

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