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.
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 30 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Easypack Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Easypack Putty will be used standalone in patients up to two-level degenerative disc disease with segmental mechanical spinal instability requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Discharge, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.
Demineralized 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.
The Washington University
St Louis, Missouri, United States
RECRUITINGRothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
RECRUITINGTennessee Orthopaedic Alliance
Nashville, Tennessee, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGRadiographic 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.
Time frame: Month 12
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
Time frame: Month 6, Month 12
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.
Time frame: Month 6
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.
Time frame: Screening, Week 2, Month 3, 6, and 12
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.
Time frame: Screening, Week 2, Month 3, 6, and 12
Neurologic Status by Physical Exam
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
Time frame: Screening, Week 2, Month 3, 6, and 12
Success Rate
Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.
Time frame: Week 2, Month 3, 6, and 12
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