Clinical Trials Logo
  1. Home
  2. Vertebral Compression Fracture
  3. NCT05676320

Investigating Bone Cement With or Without Inossia™ Cement Softener for Vertebral Compression Fractures — SOFTBONE  

Vertebral Compression Fracture Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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 150 patients will be enrolled in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05676320
Study type Interventional
Source Inossia AB
Contact Malin K Nilsson, PhD
Phone +46702688674
Email malin.nilsson@inossia.com
Status Recruiting
Phase N/A
Start date March 11, 2021
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01643395 - VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures Phase 3
Enrolling by invitation NCT05018637 - Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture Phase 2
Completed NCT03523000 - Determining the Prognostic Value of Continuous Intrathecal Infusion Phase 4
Recruiting NCT04835428 - STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures N/A
Recruiting NCT04821739 - RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures N/A
Completed NCT04135755 - The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects
Recruiting NCT04581707 - Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement
Completed NCT01383616 - Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures Phase 4
Recruiting NCT05912504 - Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey
Completed NCT06153576 - The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Completed NCT03580434 - The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System N/A
Suspended NCT03651804 - Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures Phase 4