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

Completed · Not applicable

Conditions studied: Stenosis, Spondylosis, Degenerative Changes

In brief

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.

Key facts

Study ID

NCT01430299

Run by

SeaSpine, Inc.

People needed

43

Starts

2011-06-01

Expected to finish

2016-10-01

Last updated by the study team

2018-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years of age or older at the time of surgery
• Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
• Follow-up radiographic imaging post surgery

You may not qualify if…

• Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
• Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
• Treated with radiotherapy since their surgery
• Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
• Pregnant or lactating women or women wishing to become pregnant
• Prisoner
• Participating in an investigational drug or another device study

Where it is running

• University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery — Sacramento, California, United States

Full record on ClinicalTrials.gov

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