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Xpede Clinical Study

Primary Purpose

Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xpede™ Bone Cement
Mendec Spine Bone Cement
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice.
  2. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
  3. Subjects are at least 18 and ≤80 years old .

Exclusion Criteria:

  1. Subject has a local or systemic infection.
  2. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.
  3. Subject has a medical condition with less than 1 year of life expectancy.
  4. Subject is grossly obese, i.e. BMI≥40.
  5. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.
  6. Subject has an allergy or an intolerance to bone cement component.
  7. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.
  8. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.
  9. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
  10. Subjects with exclusion criteria required by local law (age or other).
  11. Subjects with medical condition which precludes them from participation in the opinion of the Investigator.

Sites / Locations

  • The first affiliated hospital of Zhengzhou university
  • Hunan provincial people's hospital
  • The first affiliated hospital of Suzhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xpede™ Bone Cement

Mendec Spine Bone Cement

Arm Description

The subjects in this group will be injected the Xpede™ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.

The subjects in this group will be injected the Mendec Spine Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.

Outcomes

Primary Outcome Measures

The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
The Change of Index Vertebral Body Angle From Baseline at 6 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.

Secondary Outcome Measures

The Change of NRS Score From Baseline at 1 Day and 3 Months
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months
ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.
Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。
Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Number of Participants With Adverse Events Reported Through 6 Months
Adverse events reported through 6 months, in particular, the following events will be reported: Bone Cement Implantation Syndrome; Bone Cement leakage; Vertebral body compression fracture; Adjacent vertebral body fracture;

Full Information

First Posted
October 16, 2018
Last Updated
December 20, 2022
Sponsor
Medtronic Spinal and Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT03730207
Brief Title
Xpede Clinical Study
Official Title
A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xpede™ Bone Cement
Arm Type
Experimental
Arm Description
The subjects in this group will be injected the Xpede™ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
Arm Title
Mendec Spine Bone Cement
Arm Type
Active Comparator
Arm Description
The subjects in this group will be injected the Mendec Spine Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
Intervention Type
Device
Intervention Name(s)
Xpede™ Bone Cement
Intervention Description
Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
Intervention Type
Device
Intervention Name(s)
Mendec Spine Bone Cement
Intervention Description
Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
Primary Outcome Measure Information:
Title
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
Description
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame
Baseline and 6 months
Title
The Change of Index Vertebral Body Angle From Baseline at 6 Months
Description
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
The Change of NRS Score From Baseline at 1 Day and 3 Months
Description
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame
Baseline, 1 day, and 3 months
Title
The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months
Description
ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame
Baseline, 1 day, 3 months, and 6 months
Title
The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months
Description
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.
Time Frame
Baseline, 1 day, 3 months, and 6 months
Title
Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
Description
Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。
Time Frame
1 day, 3 months, and 6 months
Title
Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
Description
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time Frame
Baseline, 1 day and 3 months
Title
Number of Participants With Adverse Events Reported Through 6 Months
Description
Adverse events reported through 6 months, in particular, the following events will be reported: Bone Cement Implantation Syndrome; Bone Cement leakage; Vertebral body compression fracture; Adjacent vertebral body fracture;
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration. Subjects are at least 18 and ≤80 years old . Exclusion Criteria: Subject has a local or systemic infection. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture. Subject has a medical condition with less than 1 year of life expectancy. Subject is grossly obese, i.e. BMI≥40. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision. Subject has an allergy or an intolerance to bone cement component. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence. Subjects with exclusion criteria required by local law (age or other). Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
Facility Information:
Facility Name
The first affiliated hospital of Zhengzhou university
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hunan provincial people's hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The first affiliated hospital of Suzhou university
City
Suzhou
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

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Xpede Clinical Study

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