NCT01415908

INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine

A Prospective, Multi-center, Pivotal Trial for INFUSE® Bone Graft With CAPSTONE® Spinal System and Posterior Supplemental Fixation to Treat 1- or 2-level Advanced Degenerative Disease of the Lumbosacral Spine For a TLIF Approach

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.

Detailed description

The study is a prospective, multi-national study that compares INFUSE® Bone Graft (investigational group) to autogenous bone graft (control group). Control group subjects will receive the same surgical treatment except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. All sites will follow a common Clinical Investigational Plan (CIP) that consists of the protocol and accompanying case report forms, risk analysis, investigator's agreement, subject informed consent, institutional review board (IRB) certification, labeling, and monitoring information.

Conditions

• Lumbar Spine Degeneration

Interventions

Type	Name	Description
DEVICE	INFUSE Bone Graft	Subjects enrolled in the investigational treatment group will receive surgical treatment with INFUSE® Bone Graft, the CAPSTONE® Spinal System, and posterior supplemental fixation (in this study the CD HORIZON® Spinal System). The investigational treatment will be implanted using a TLIF surgical approach.
OTHER	Iliac Crest Bone Graft	Subjects enrolled in the control group will receive the same surgical treatment as the investigational group, including the CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System), except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. A TLIF surgical approach will also be used for implanting the control treatment.

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-09-01
• Completion: 2015-01-01
• First posted: 2011-08-12
• Last updated: 2016-02-18
• Results posted: 2015-10-28

Locations

5 sites across 1 country: United States