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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stenosis, Spondylosis, Degenerative Changes

Intervention / Treatment
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* Device: Demineralized Bone Matrix
* Device: rh-BMP2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Demineralized Bone Matrix<br>a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space | Device: Demineralized Bone Matrix<br>* Accell Evo3 in posteriolateral fusion (prospective cohort)<br>* Other names: Accell Evo3;|
| Other: rh-BMP2<br>A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2 | Device: rh-BMP2<br>* rh-BMP2 in posterolateral fusion (retrospective cohort)<br>* Other names: Infuse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | Posterolateral fusion by radiographic assessment 12 months post surgery | 12 months |