NCT02628210

Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: RTI Surgical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Spondylosis
• Spondylolisthesis
• Degenerative Disc Disease

Interventions

Type	Name	Description
OTHER	map3® Cellular Allogeneic Bone Graft	Patients will receive map3® Cellular Allogeneic Bone Graft

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-12-11
• Last updated: 2021-05-24

Locations

3 sites across 1 country: United States