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Clinical Trial Summary

This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.


Clinical Trial Description

The evaluation is based on the following elements. 1. Safety as measured by the rate of serious operative and post-operative complications. 2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline. 3. Global and segmental lumbar lordosis (LL) Patients will be followed upto 24 months post-operative ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03162666
Study type Observational
Source Globus Medical Inc
Contact
Status Withdrawn
Phase
Start date February 28, 2017
Completion date November 6, 2020

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