NCT04495439

Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures

Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-Screw Augmentation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Nexilis AG · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture. The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.

Conditions

• Osteoporotic Fracture of Vertebra

Interventions

Type	Name	Description
DEVICE	Augmentation with the ISS Study System	Augmentation with the ISS Study System
OTHER	Augmentation with PMMA	Augmentation with PMMA (standard)

Timeline

• Start date: 2019-09-11
• Primary completion: 2020-09-14
• Completion: 2022-10-25
• First posted: 2020-07-31
• Last updated: 2024-02-09

Locations

1 site across 1 country: Austria