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OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

NCT00764491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-09-16

Study results available
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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.

Conditions

  • Degeneration of Lumbar Intervertebral Disc

Interventions

DEVICE

Structural Allograft Spacer

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

DEVICE

OptiMesh 1500S

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.

Sponsors & Collaborators

  • Spineology, Inc

    lead INDUSTRY

Principal Investigators

  • Martin Krag, MD · Fletcher-Allen Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2012-11-30
Completion
2013-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764491 on ClinicalTrials.gov