Research Knowledge Forum SCI Q3 Report

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1 Research Knowledge Forum SCI 2015-Q3 Report

2 Steering committee Michael Fehlings (Chairman) University of Toronto Toronto, Canada Start of Term: 01 Apr 2013 End of Term: 30 Jun 2016 Robert Grossman Bizhan Aarabi The Methodist Hospital University of Maryland Houston, USA Baltimore, USA Start of Term: 01 Jan 2012 Start of Term: 01 Jan 2012 End of Term: 31 Dec 2017 End of Term: 31 Dec 2017 Shekar Kurpad Brian Kwon Froedtert & the Medical College of Wisconsin University of British Columbia Milwaukee, USA Vancouver, Canada Start of Term: 01 Jun 2015 Start of Term: 01 Jun 2015 End of Term: 31 May 2018 End of Term: 31 May 2018 James Harrop Thomas Jefferson University Philadelphia, USA Start of Term: 01 Jun 2015 End of Term: 31 May 2018 New Knowledge Forum Manager María Alvarez Sánchez AOSpine International Clavadelerstrasse Davos Switzerland T malvarez@aospine.org

3 Projects RISCIS Title: A Multi-Center, Randomized, Placebo-Controlled, Double- Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury Principal Investigator: Michael Fehlings Co-Investigators: Open call for applications completed; eight sites enrolled. Aim: The aim of this study is to evaluate efficacy and safety of Riluzole in the treatment of patients with acute spinal cord injury. The primary objective is to evaluate the superiority of Riluzole as compared to placebo, in improving motor outcomes as measured by ASIA Motor Score at 6 months follow-up, in patients with acute traumatic spinal cord injury, presenting to hospital less than 12 hours after injury. Co-sponsoring: AOSpine North America, U.S. Department of Defense, Christopher and Dana Reeve Foundation, Ontario Neurotrauma Foundation, Rick Hansen Institute. Participating sites: Local PI Surname Name Institute City Country Region Recruited patients Fehlings Michael Toronto Western Hospital Toronto Canada NA Ball Jonathon Royal North Shore Hospital Sydney Australia AP 3 Aarabi Bizhan University of Maryland Baltimore USA NA 8 Shaffrey Christopher University of Virginia Charlottesville USA NA 4 Brooks Nathaniel University of Wisconsin Madison USA NA Harrop James Jefferson University Philadelphia USA NA 2 Nassr Ahmad The Mayo Clinic Rochester USA NA 4 Brodke Darrel University of Utah Salt Lake City USA NA 1 Arnold Paul Kansas University Medical Center Kansas City USA NA 3 Kurpad Shekar Medical College of Wisconsin Milwaukee USA NA Theodore Nicholas Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Phoenix USA NA Ray Wilson Washington University St. Louis USA NA Stanford Ralph Prince Wales Hospital Sydney Australia AP 5 Schuster James University of Pennsylvania Philadelphia USA NA 5 Ahn Henry St. Michael's Hospital Toronto Canada NA Publications: Abstract submitted: 1 Podium presentations: 7 Manuscripts submitted: 0 Manuscript published: 4 Awards & Nominations: Nominated for the White Cloud Award at the 21st IMAST International Awarded with the Trauma and Critical Care Third Place Eposter Award. Status: Executing data collection

4 SCI Database Merge Title: Spinal Cord Injury (SCI) Database Merge: Combining data of two existing registries (NACTN and STASCIS) Principal Investigator: Michael Fehlings Aim: To combine two existing databases on patients with spinal cord injuries treated surgically (NACTN and STASCIS) and to assess descriptive data on injury/surgery details, as well as ASIA score and reported complications. Publications: Abstracts presented: 0 Manuscripts: 0 Awards & Nominations: None Status: Executing data analysis SCI Guideline project (co-sponsoring AOSpine North America) Title: Development of an Evidence-based Clinical Guideline for the Treatment of Acute Spinal Cord Injury Principal Investigator: Michael Fehlings Co-Investigators: Open call for applications completed; eight sites enrolled. Co-sponsoring: AOSpine North America Aim: A set of systematic reviews will serve as the basis of the current state of the field. Based on this knowledge, a global team of clinical experts in SCI will then go through the rigorous process of developing evidence-based clinical guidelines for the treatment of Acute Spinal Cord Injury specific to the five selected topics: Use of methylprednisolone Timing of decompression Role and timing of magnetic resonance imaging Type and timing of anticoagulation Type and timing of rehabilitation Publications: Abstracts presented: 0 Manuscripts: 0 Awards & Nominations: None Status: Executing data collection

5 Publication Summary Abstracts Submitted (under review) 1. Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). Congress Spine Research Society (CSRS), San Diego, CA. December 3-5, Accepted for Presentation Podium Presentations: E-poster Presentations: 1. Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). North American Spine Society Annual Meeting. Chicago, IL. October 14-17, Presented Podium Presentations: 1. Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). International Meeting on Advance Spine Techniques (IMAST). Kuala Lumpur, Malaysia. July 8-11, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). ASIA/ISCoS Joint Scientific Meeting [American Spinal Injuria Association and International Spinal Cord Society]. Montreal, Canada. May 14-16, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). AO ONE Conference. Las Vegas, NV. February 5-7, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). North American Spine Society (NASS) Meeting. San Francisco, CA. November 12-15, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). Congress of Neurological Surgeons (CNS) Meeting. Boston, MA. October 18-22, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). International Meeting on Advanced Spine Techniques (IMAST). Valencia, Spain. July 16-19, Fehlings MF, Kopjar B, Grossman R. Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI). Rationale and Design of AOSpine Phase III Multi-center Double Blind Randomized Controlled Trial. (RISCIS). SRS 20th Annual International Meeting on Advanced Spine Techniques (IMAST). Vancouver, Canada. July 10-13, 2013.

6 E-poster Presentations: 1. Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). Global Spine Congress (GSC) Buenos Aires, Argentina. May 20-23, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). American Association of Neurological Surgeons (AANS) Annual Meeting. Washington DC. May 2-6, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves. Phoenix, Arizona. March 4-7, Fehlings, MF, Kopjar, B, Grossman, R. Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI). Rationale and Design of AOSpine Phase III Multi-center Double Blind Randomized Controlled Trial. (RISCIS). American Association of Neurological Surgeons (AANS) Annual Meeting. San Francisco, CA. April 5-9, Fehlings MF, Grossman R, Wilson J, Frankowski R, Kopjar B, Burau K, Chow D, Tator C, Teng A, Toups E, Harrop J, Aarabi B, Shaffrey C, Johns M. The Clinical Translation of Riluzole for the Treatment of Traumatic Spinal Cord Injury: Design of a Phase II/III Trial. 63 rd Annual Meeting of the Congress of Neurological Surgeons (CNS). San Francisco CA, October 19-23, Fehlings, MF, Kopjar, B, Grossman, R., Wilson, J. (RISCIS). Congress of Neurological Surgeons (CNS) Annual Meeting. New Orleans, LA. September 27-30, Manuscripts Submitted Published 1. Nagoshi, N., H. Nakashima and M. G. Fehlings (2015). "Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside." Molecules 20(5): Fehlings, M. G., H. Nakashima, N. Nagoshi, D. S. Chow, R. G. Grossman and B. Kopjar (2015). "Rationale, design and critical end points for the Riluzole in Acute Spinal Cord Injury Study (RISCIS): a randomized, doubleblinded, placebo-controlled parallel multi-center trial." Spinal Cord. 3. Fehlings, M. G., J. R. Wilson, R. F. Frankowski, E. G. Toups, B. Aarabi, J. S. Harrop, C. I. Shaffrey, S. J. Harkema, J. D. Guest, C. H. Tator, K. D. Burau, M. W. Johnson and R. G. Grossman (2012). "Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial." J Neurosurg Spine 17(1 Suppl): Tator, C. H., R. Hashimoto, A. Raich, D. Norvell, M. G. Fehlings, J. S. Harrop, J. Guest, B. Aarabi and R. G. Grossman (2012). "Translational potential of preclinical trials of neuroprotection through pharmacotherapy for spinal cord injury." J Neurosurg Spine 17(1 Suppl): Book Chapters 1. M. Fehlings, N. Nagoshi, H. Nakashima. Pathobiology of spinal cord injury. In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press). 2. Kwon, B. Serum and CSF Biomarkers to Predict Functional Recovery after Spinal Cord Injury. In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press). 3. J. Cohen-Adad, A. Martin, M. Fehlings. Magnetic resonance imaging of the injured spinal cord: the present and the future. In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press). 4. G. Hawryluk, M. Fehlings. Acute non-operative management of traumatic spinal cord injury state of the art. In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press). 5. M. Fehlings, C. Witiw. Role and timing of surgery for traumatic spinal cord injury What do we know? What should we do? In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press).

7 6. J. Wilson, M. Fehlings. Methylprednisolone for acute spinal cord injury: a re-assessment of the literature. Is this drug an option? In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press). 7. M. Fehlings, C. Ahuja. Neuroprotection of the injured spinal cord What does the future hold? In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7. New York: Thieme. (in press).

8 AOSpine International T Clavadelerstrasse 8 F Davos Platz research@aospine.org Switzerland

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