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.
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 (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
Requires > two-level fusion or expected to need secondary intervention within one year following surgery.
Had prior PLF fusion or attempted PLF fusion at the involved levels.
Had previous decompression at the involved levels.
Women who are or intend to become pregnant within the next 12 months.
Kuros Biosurgery AG
Lead sponsor
Simplified Clinical Data Systems, LLC
Collaborator
Kuros BioSciences B.V.
Collaborator