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.
Parallel
MagnetOs Easypack Putty
DeviceMagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.
Demineralized Bone Matrix or Fibers mixed with local autograft bone
DeviceDemineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Functional Outcome by Oswestry Disability Index Questionnaire
Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability or bedridden.
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
Change in back and leg pain using Visual Analog Pain Scale (0-100). Patient-completed questionnaire scoring pain by using 100 mm line. Zero being no pain, 100 is worst pain imaginable.
Safety Endpoint - number of patients with Adverse Events
The number of patients with Adverse Events from Screening up to Month 12 after surgery.
Safety Endpoint - number of patients with Serious Adverse Events
The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
Safety Endpoint - number of patients with Adverse Device Effects
The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
Safety Endpoint - number of patients with Device Related Complications
The number of patients with any complications considered to device related with 12 months after surgery.
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Kuros Biosurgery AG
Lead sponsor
Simplified Clinical Data Systems, LLC
Collaborator
Kuros BioSciences B.V.
Collaborator
