MedTrace Logo

Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion

NCT01430299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-06-07

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Stenosis
  • Spondylosis
  • Degenerative Changes

Interventions

DEVICE

Demineralized Bone Matrix

Accell Evo3 in posteriolateral fusion (prospective cohort)

DEVICE

rh-BMP2

rh-BMP2 in posterolateral fusion (retrospective cohort)

Sponsors & Collaborators

  • SeaSpine, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Klineberg, M.D. · University of CA - Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-03-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01430299 on ClinicalTrials.gov