A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse Bone Graft With Mastergraft Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
Phase of Trial: Phase II
Latest Information Update: 03 Nov 2018
At a glance
- Drugs Dibotermin alfa (Primary)
- Indications Spinal disorders; Spondylolisthesis
- Focus Therapeutic Use
- Acronyms BONE
- 05 Sep 2017 According to a Medtronic media release, the first patient has been enrolled in this trial.
- 05 Sep 2017 According to a Medtronic media release, this trial is a part of the global clinical program called BONE (BMP Outcomes and New Evidence in PLF and TLIF Procedures). The current plan for the prospective, multi-center, ten-year program will include approximately 40-50 sites and 550-700 patients between the Pilot and Pivotal studies of both procedures. If successful, the Pilot studies would be followed by a larger Pivotal study.
- 27 Apr 2017 Status changed from not yet recruiting to recruiting.