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

NCT04495439 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-02-09

No results posted yet for this study

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

DEVICE

Augmentation with the ISS Study System

Augmentation with the ISS Study System

OTHER

Augmentation with PMMA

Augmentation with PMMA (standard)

Sponsors & Collaborators

  • Nexilis AG

    lead INDUSTRY

Principal Investigators

  • Richard Lindtner, M.D · Department of Trauma Surgery, Medical University of Innsbruck, Austria

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2020-09-14
Completion
2022-10-25

Countries

  • Austria

Study Locations

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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 NCT04495439 on ClinicalTrials.gov