Research Source
The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.
This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control).
Inclusion Criteria: 1. At least 22years of age at the time of consent 2. Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as: 1. Instability as defined by \>3mm translation or \>5 degree angulation 2. Osteophyte formation of facet joints or vertebral endplates 3. Subject presents with one or more of the following: 1. Radiculopathy 2. Sensory deficit 3. Motor weakness 4. Reflex changes 4. Subject requires lumbar posterolateral arthrodesi…
Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1)
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