CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
SIFS graft containment devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02347410
NCT02347410N/ACompleted
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Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

Spineology, Inc·interventional·Posted Jan 27, 2015·Updated Oct 20, 2021

In Brief

A clinical study evaluating SIFS graft containment device for Lumbar Degenerative Disc Disease. Completed, enrolled 102 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Degenerative Disc Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 27, 2015
Enrollment StartJan 22, 2015
Primary CompletionJan 22, 2020
Study CompletionMar 4, 2020
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 11.4 years ago

Interventions

SIFS graft containment devicedevice

The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.