NCT05676320

Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Inossia AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The clinical investigation is a prospective, single-blind, controlled multi-center study of vertebral compression fractures treated by vertebroplasty or kyphoplasty with PMMA alone (V-Steady) or PMMA mixed with Inossia® Cement Softener (V-Flex). The overall purpose of conducting this study is to confirm the safety and efficacy of Inossia® Cement Softener mixed with PMMA for augmentation of osteoporotic vertebral compression fractures and to verify that the V-Flex is, at least, comparable (non-inferior) to the PMMA products used today. All eligible patients will be invited to participate in the study. A total of 203 patients were enrolled in the study.

Conditions

• Vertebral Compression Fracture

Interventions

Type	Name	Description
DEVICE	V-Flex	Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
DEVICE	V-Steady	Bone Cement alone

Timeline

• Start date: 2021-03-11
• Primary completion: 2025-10-20
• Completion: 2026-05-01
• First posted: 2023-01-09
• Last updated: 2026-04-08

Locations

9 sites across 4 countries: Canada, Germany, Poland, Spain