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

SeaSpine, Inc.43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stenosis Spondylosis Degenerative Changes

Interventions

Demineralized Bone MatrixDEVICE

Accell Evo3 in posteriolateral fusion (prospective cohort)

rh-BMP2DEVICE

rh-BMP2 in posterolateral fusion (retrospective cohort)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery

Sacramento, California, United States

Outcomes

Primary Outcomes

Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery

Posterolateral fusion by radiographic assessment 12 months post surgery

Time frame: 12 months

Data from ClinicalTrials.gov

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