Study Results
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View full resultsBasic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2018-12-18
2021-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Xpede™ Bone Cement
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.
Xpede™ Bone Cement
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.
Mendec Spine Bone Cement
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.
Mendec Spine Bone Cement
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.
Interventions
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Xpede™ Bone Cement
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.
Mendec Spine Bone Cement
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
11. Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China
Hunan provincial people's hospital
Changsha, Hunan, China
The first affiliated hospital of Suzhou university
Suzhou, Jiangsu, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT17075SD1707
Identifier Type: -
Identifier Source: org_study_id
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