map3

A Prospective, Multi-Center, Non-Randomized Study to Assess Clinical Outcomes Using Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior Lumbar Interbody Fusion or Lateral Lumbar Interbody Fusion

map3 [NCT02628210]

Description: 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.

Device: map3® Cellular Allogeneic Bone Graft

Primary Investigator: Chunduri

Drug/Device Information
Assess clinical and radiographic outcomes following anterior (ALIF) or lateral lumbar interbody fusion (LLIF) using allograft interbody spacers with map3 cellular allogeneic bone graft
Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone
MAPC-based cells derived from allograft bone marrow, isolated from other cells and cryopreserved
Both the scaffold and cellular constituents are processed from the same donor
Non-randomized
RTI Surgical Inc.