A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion

Korábbi kezelés

• Subject has had prior lumbar spine fusion surgery at any level.

Más betegség

• Subject has an active local or systemic infection.
• Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol

Egyéb

• Subject has greater than grade 1 spondylolisthesis of the lumbar spine.
• Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
• Subject is a prisoner

• At least 22years of age at the time of consent
• 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:
  • Instability as defined by >3mm translation or >5 degree angulation
  • Osteophyte formation of facet joints or vertebral endplates
• Subject presents with one or more of the following:
  • Radiculopathy
  • Sensory deficit
  • Motor weakness
  • Reflex changes
• Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1).
• The number of levels decompressed must equal the number of levels fused.
• Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery.
• Subject must be willing and able to sign an informed consent document.
• Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.