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Xpede Clinical Study

NCT03730207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-01-10

Study results available
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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.

Conditions

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2021-10-14
Completion
2021-10-14
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730207 on ClinicalTrials.gov