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Spineology Clinical Outcomes Trial: An IDE Investigation — SCOUT  

Lumbar Degenerative Disc Disease Clinical Trial

Official title:
Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

Clinical Trial Summary

This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Clinical Trial Description

This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated. Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months. The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02347410
Study type Interventional
Source Spineology, Inc
Contact
Status Completed
Phase N/A
Start date January 22, 2015
Completion date March 4, 2020
View Details
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