MedTrace Logo

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

NCT05676320 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2026-04-08

No results posted yet for this study

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).

Conditions

  • Vertebral Compression Fracture

Interventions

DEVICE

V-Flex

Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture

DEVICE

V-Steady

Bone Cement alone

Sponsors & Collaborators

  • EIT Health

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • Inossia AB

    lead INDUSTRY

Principal Investigators

  • David Noriega · University Hospital in Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2025-10-20
Completion
2026-05-31

Countries

  • Canada
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT05676320 on ClinicalTrials.gov