NCT01430299

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

Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: SeaSpine, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.

Conditions

• Stenosis
• Spondylosis
• Degenerative Changes

Interventions

Type	Name	Description
DEVICE	Demineralized Bone Matrix	Accell Evo3 in posteriolateral fusion (prospective cohort)
DEVICE	rh-BMP2	rh-BMP2 in posterolateral fusion (retrospective cohort)

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-03-01
• Completion: 2016-10-01
• First posted: 2011-09-08
• Last updated: 2018-06-07
• Results posted: 2018-02-28

Locations

1 site across 1 country: United States