Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Trial Parameters
Brief Summary
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
Eligibility Criteria
Inclusion Criteria: * Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent. * Male or female patient ≥ 18 years old. * Patients with segmental mechanical spinal instability requiring arthrodesis surgery. Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following: 1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs), 2. decreased disc height by \> 2 mm, but dependent upon the spinal level 3. Grade II or more listhesis 4. TLICS equal or greater than 5 5. Unstable burst fracture * Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or tr