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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04495439
Study type Interventional
Source Nexilis AG
Contact
Status Terminated
Phase N/A
Start date September 11, 2019
Completion date October 25, 2022

See also
  Status Clinical Trial Phase
Completed NCT04660825 - Development and Evaluation of an Exercise Intervention for Prevention of Vertebral Osteoporosis and Deformity in Postmenopausal Women N/A
Not yet recruiting NCT03682328 - Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures. N/A
Recruiting NCT05519332 - Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures N/A