This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone and multipotent adult progenitor cells (MAPC). MAPC-based cells are derived from allograft bone marrow, isolated from other cells and cryopreserved. Both the scaffold and cellular constituents are processed from the same donor but are provided in separate containers. Scaffold and cells combined constitute the implant and must be used together. The map3 implant is available in Strips allograft and Chips allograft configurations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients will receive map3® Cellular Allogeneic Bone Graft
Spine Surgery of Buffalo Niagara, LLC
Niagara Falls, New York, United States
AXIS Neurosurgery and Spine of WNY, PLLC
Williamsville, New York, United States
Carl & Edyth Lindner Center for Research The Christ Hospital
Cincinnati, Ohio, United States
Change in the Oswestry Disability Index (ODI)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Fusion
Fusion at the operated level, based on * Bridging trabecular bone. * Less than 3 mm of translational motion. * Less than 5 degrees of angular motion.
Time frame: 6 months, 12 months and 24 months
Changes in Visual Analog Scale (VAS) pain scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in SF-36 scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in Lumbar Intervertebral Disc (LID) scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in medication use
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Time to return to work
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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