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Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion

NCT01714804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-23

Study results available
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Summary

The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient cohort.

Conditions

  • Stenosis
  • Spondylosis
  • Degenerative Changes

Interventions

DEVICE

Accell Evo3 Prospective Use

Sponsors & Collaborators

  • SeaSpine, Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Youssef, MD · Spine Colorado

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-07-31
Completion
2016-10-31

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 NCT01714804 on ClinicalTrials.gov