At a glance
ClinicalIndex Comparison RecordN/AActive· 203 enrolled
Drug / intervention
V-Flex +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.
A Multicentre, Single-blind, RCT to Document the Safety and Efficacy of the Use of a Bone Cement With or Without Inossia® Cement Softener for Patients With Vertebral Compression Fractures
In Brief
A clinical study evaluating V-Flex and V-Steady for Vertebral Compression Fracture. Active but no longer recruiting, targeting 203 participants across 9 sites in 4 countries.
Detailed Summary
The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA bone cement is comparable to a PMMA bone cement alone (V-Steady).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVertebral Compression Fracture
CountriesCanada, Germany, Poland, Spain
CollaboratorsEIT Health, Uppsala University
Timeline
N/AActiveOverdue
20222023202420252026
Enrollment StartMar 2021
First PostedJan 2023
Primary CompletionOct 2025
Study CompletionMay 2026
TodayJul 2026
First PostedJan 9, 2023
Enrollment StartMar 11, 2021
Primary CompletionOct 20, 2025
Study CompletionMay 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 3.5 years ago
Interventions
V-Flexdevice
Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
V-Steadydevice
Bone Cement alone