CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
Structural Allograft Spacer +1 moredevice
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/NCT00764491
NCT00764491N/ACompleted
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OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

Spineology, Inc·interventional·Posted Oct 2, 2008·Updated Sep 16, 2021

In Brief

A clinical study evaluating Structural Allograft Spacer and OptiMesh 1500S for Degeneration of Lumbar Intervertebral Disc. Completed, enrolled 156 participants across 11 sites.

Detailed Summary

The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition requires an interbody spinal fusion procedure combined with posterior fixation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegeneration of Lumbar Intervertebral Disc
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2008
Enrollment StartJul 1, 2003
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 17.8 years ago

Interventions

Structural Allograft Spacerdevice

Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.

OptiMesh 1500Sdevice

Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.