CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Xpede™ Bone Cement +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03730207
NCT03730207N/ACompleted
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A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial

Medtronic Spinal and Biologics·interventional·Posted Nov 5, 2018·Updated Jan 10, 2023

In Brief

A clinical study evaluating Xpede™ Bone Cement and Mendec Spine Bone Cement for Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) and Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder). Completed, enrolled 180 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartDec 18, 2018
Primary CompletionOct 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.7 years ago

Interventions

Xpede™ Bone Cementdevice

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 Cementdevice

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.