Research Studies and Publications

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Research Studies and Publications

Research Studies

Dr. Michael Janssen has participated in numerous research studies, including those in which he was a principal investigator:

Centinel Spine Clinical Study for Total Disc Replacement for Two-Level Symptomatic Cervical Disc Disease This is a randomized controlled trial comparing the safety and effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the treatment of two-level symptomatic cervical disc disease. (Principal Investigator)
- - NCT04012996
Aspire Trial: A New Alternative to Spinal Fusion – This research study has been designed to determine if the use of P-15L Bone Graft is as good at fusing bones surrounding your damaged disc as using your own bone and possibly donor bone following a spinal fusion surgery. (Principal Investigator)
- - TITLE: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion with Instrumentation
  - NCT03438747
Investigation of the Two-Level Simplify® Cervical Artificial Disc – This study is intended to demonstrate that the Simplify® Cervical Artificial Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management. (Principal Investigator)
- - NCT03123549
Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
- - NCT04630626
Investigation of the Simplify® Cervical Artificial Disc
- - NCT02667067
Feasibility study of “Contact Fusion Cage” for posterior lumbar interbody stabilization (Completed)
A safer Posterior Lumbar Interbody Fusion Contact Fusion Cage – Randomized, prospective study (Completed)
Titanium Interbody Spacer – Randomized prospective study (Completed)
Femoral Ring Allograft – Clinic experience with custom femoral ring allograft for anterior column support in the lumbar spine (Completed)
Cervical Ring Allograft – Clinic experience with custom cervical ring allograft for anterior cervical spine fusion (Completed)
Cervical Spine Locking Plate – Clinic experience with five-year follow-up on survivorship analysis of anterior cervical spine plating with use of the cervical spine locking plate (Completed)
Posterior Cervical Screw and Rod Construct for Reconstruction of the Cervical Spine Multi-center prospective randomized controlled clinical trial comparing the safety and effectiveness of ProDisc-C® for anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (Principal Investigator)
- - NCT00291018
Randomized, Third-party Blinded, Multi-center, Clinical Trial to Determine the Safety and Effectiveness of Oxiplex®/SP Gel for the Reduction of Pain and Symptoms Following Lumbar Disc Surgery (Completed)
- - NCT03433391
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc® total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with degenerative disc disease (DDD) in the lumbosacral spine. (Principal Investigator)
- - NCT00295009
Clinical Study comparing posterior flexile stabilization of the lumbar spine with the Stabilimax NZth Dynamic Stabilization system to posterior lateral instrumented fusion (Principal Investigator)
- - NCT00529997
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation, Principal Investigator
- - NCT00310440
An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy (Principal Investigator)
- - NCT00285337

For a complete list of publications, see Dr. Janssen’s CV.

Publications

Journal of Neurosurgery, submitted for publication, “Segmental Motion of Cervical Arthorplasty Leads to Decreased Adjacent Level Degeneration: Post-hoc Analysis of the 7 Year Postoperative Results of a Multicenter Randomized Controlled Trial”. February 2021.
“Improving blood product utilization at an ambulatory surgery center: a restrospective cohort study on 50 patients with lumbar disc replacement”. Patient Safety in Surgery. 2019
The Spine Journal, October 2017. “Challenges and Solutions for Lumbar Total Disc Replacement Implantation. First Author, Submitted by Caitlin Coles 10-2017.
“Foreword: Proceedings from the First Annual Lumbar Total Disc Replacement Summit” Spine (Phila PA 1976). 2017 Dec 15.
International Journal of Spine Surgery, “Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies” published. IJSSURGERY-D-15-00097R1. Volume 10 Article 33. September 22, 2016.
“Five-Year Reoperation Rates of Two Level Lumbar Total Disc Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial” Clinical Spine Surgery, 2016.
The Journal of Bone and Joint Surgery, Volume 97-A, Number 21. November 4, 2015. “ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease.
The Spine Journal, Volume 15, Number 10S, October 2015. “The Benefit of Continued Motion of a Cervical Artificial Disc Replacement on Radiographic Adjacent Level Degeneration at 7-Year Follow Up”. Jeffery Spivak, Jack Zigler and Michael Janssen
Geographical Variations in Clinical Presentation and Outcomes of Decompressive Surgery in Patients with Symptomatic Degenerative Cervical Myelopathy: Analysis of a Prospective, International Multicenter Cohort Study of 757 Patients. Submitted for publication.
The Spine Journal, Volume 15, Number 10S, October 2015. “Efficacy of a Novel Synthetic Small Peptide in Anterior Cervical Arthrodesis: A Randomized, Controlled, Multicenter Study with 24 Month Follow Up”. Rick Sasso, Alex Vacarro, Michael Fehlings, and Michael Janssen.
Zigler, J. E., Delamarter, R., Murrey D., Spivak, J., Janssen, M. (2013). ProDisc-C and Anterior Cervical Discectomy and Fusion as Surgical Treatment for Single-Level Cervical Symptomatic Degenerative Disc Disease: Five-Year Results of a Food and Drug Administration Study. Spine, 38 (3), 203-209.
Barry, S., Fehlings, M.G., Kopjar, B., et al. (2013). Anterior vs Posterior surgical approaches to treat cervical spondylotic myelopathy: Outcomes of the prospective multicenter AOSpine North America CSM Study in 264 patients.
Fehlings, M.G., Wilson, J.R., Kopjar, B., et al. (2013). Efficacy and Safety of Surgical Decompression in Patients with Cervical Spondylotic Myelopathy: Results of the AOSpine North America Prospective Multi-Center Study. JBJS, 95, 1651-1658.
Arnold, P.M., Fehlings, M.G., Kopjar, B., et al. (2013). Impact of Diabetes on Outcomes of Surgical Decompression for Cervical Spondylotic Myelopathy: Results of the AOSpine North America Multi-Center Prospective Study (CSM). The Spine Journal.
Perioperative and Delayed Complications Associated with the Surgical Treatment of Cervical Spondylotic Myelopathy Based on 302 Patients from the AOSpine North America Cervical Spondylotic Myelopathy Study – Submitted for Publication Summer of 2011

For a complete list of publications, see Dr. Janssen’s CV.