Charles Ledonio, MD, CCRP

Minneapolis, MN

612-***-****

ac1a34@r.postjobfree.com

www.linkedin.com/in/charlesledoniomd

x Clinical Research Methodology

x Process Improvement

x Operations Management

x Team Building & Leadership

x Clinical Knowledge

x Systematic Literature Reviews

x Clinical Trial/Research Management/Monitoring

x Budgeting & Forecasting

x Project Management

x Contract Negotiations

x Presentation Skills

x Meta Analysis of Clinical Evidence

Gustilo Medical Education Center - Minneapolis, MN 2007 - 2008 Oඋඍ ඈඉൺൾൽ ർ Rൾඌൾൺඋർ Fൾඅඅඈඐඌ ඉ

TRIA Orthopaedic Center - Bloomington, MN 2006

Oඋඍ ඈඉൺൾൽ ർ/Sඉඈඋඍඌ Mൾൽ ർ ඇൾ Rൾඌൾൺඋർ Fൾඅඅඈඐඌ ඉ

Nobuhara Hospital and Institute of Biomechanics - Tatsuno City, Hyogo, Japan 2004 S ඈඎඅൽൾඋ Sඎඋ ൾඋඒ ൺඇൽ B ඈආൾർ ൺඇ ർඌ

Kobe University Department of Orthopaedics - Kobe City, Japan 2004 Sൺ ൺඍൺ-Kඈൻൾ Tඋൺඏൾඅඅ ඇ Fൾඅඅඈඐඌ ඉ

Makati Medical Center, Department of Orthopaedic Surgery - Makati City, Philippines 2003 - 2004 C ൾൿ Rൾඌ ൽൾඇඍ ඇ Oඋඍ ඈඉൺൾൽ ർ Sඎඋ ൾඋඒ

Makati Medical Center, Department of Orthopaedic Surgery - Makati City, Philippines 2000 - 2004 Rൾඌ ൽൾඇർඒ ඇ Oඋඍ ඈඉൺൾൽ ർ Sඎඋ ൾඋඒ

Philippine Orthopaedic Center - Quezon City, Philippines 1999 Rൾඌ ൽൾඇർඒ ඇ Tඋൺඎආൺඍඈඅඈ ඒ

University of Santo Tomas, Faculty of Medicine and Surgery - Manila, Philippines 1993 - 1998 Dඈർඍඈඋ ඈൿ Mൾൽ ർ ඇൾ ൺඇൽ Sඎඋ ൾඋඒ

University of Santo Tomas - Manila, Philippines 1988 - 1993 Bൺർ ൾඅඈඋඌ ඇ Sർ ൾඇർൾ - Pඌඒർ ඈඅඈ ඒ Mൺ ඈඋ

Accomplished Research Director and Orthopaedic Surgeon with more than nine years of research experience. Led an effort to secure over $1M in funding for the Spine Research program. Operationalized research projects within the department of Orthopaedic Surgery/Spine division. Managed over ten projects at a time including multi-site clinical trials throughout the United States and Canada. University of Minnesota - Department of Orthopaedic Surgery 2014 - Present D උൾർඍඈඋ ඈൿ Sඉ ඇൾ Rൾඌൾൺඋർ

Responsible for advancing the Spine Research Group’s mission by developing and implementing the strategic research visions of conducting clinical (and basic science) research for better patient care. Facilitated and managed the growth of research conducted by research collaborators to meet the goals, priorities and objectives in Medical Device development. Which included the comparative effectiveness research, cost effectiveness research and clinical outcome research. Worked with the Chief of Spine Service and faculty

(as Principal Investigator or Co-Investigator) to help design, conduct and present clinical research (including comparative effectiveness research) developed partnerships, helped acquire research funding and utilize resources to accomplish goals.

x Successfully facilitate projects to their completion and had publications of findings in peer review scientific journals.

x Dissemination of research findings through podium and poster presentations in various national and international medical and surgical conferences.

x Train and supervise data collection personnel for several projects at a time. x Collaborate to design, implementation, and evaluation of clinical, comparative effectiveness, cost effectiveness, basic and biochanical research studies, specifically: x Research protocol and clinical study design development x Collaborate with statistician in statistical plan development based on study objectives x DSMB criteria development

x Identification of appropriate patient reported outcome measures/questionnaires x Adverse events reporting criterion and evaluation University of Minnesota - Department of Orthopaedic Surgery 2008 - 2014 Rൾඌൾൺඋർ Aඌඌඈർ ൺඍൾ

Worked on research projects in several capacities, including that of Principal Investigator. Participated intellectually with faculty, residents and graduate students. Occasionally taught within the individual's area of research. Directed daily activities for the clinical study associates and other team members and monitor program metrics to ensure consistent and predictable study progress. x Ensured consistent study execution through the development of supporting study documents. x Clinical Investigation Plans, Case Report Forms, Data Management Plans, and Monitoring Plans. x Determined study objectives, strategy, scope, and schedule in order to meet the timelines of the sponsor. x Actively identified issues and challenges to programs success. Developed and implement appropriate solutions while forecasting appropriate timelines for the clinical study. x Conducted literature reviews to support regulatory filings and determined clinical trial strategies and prepared clinical trial protocols.

x Participated in the design, implementation, and evaluation of research studies. x Prepared research projects for grant applications as well as draft manuscripts of research efforts. x Collected data and developed data collection instruments and procedures. x Trained and supervised data collection personnel and Orthopaedic Residents. x Designed, organized, and implemented project database; analyzed data, implemented research protocols, administered multicenter clinical trials or research projects, completion and close-out projects. x Collaborated in the preparation of presentations for lectures, research papers, podium presentations, and medical posters.

Tokyo Healthlink - Philippines 2005

Aඌඌ ඌඍൺඇඍ Mൾൽ ർൺඅ D උൾർඍඈඋ

C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, ඈ, MD, CCRP RP

C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

1. Ledonio CG, Polly DW Jr, Swiontkowski MF, Cummings JT Jr. Comparative Effectiveness of Open Versus Minimally Invasive Sacroiliac Joint Fusion. Med Devices (Auckl). 2014 Jun 5;7:187-93. doi: 10.2147/ MDER.S60370. eCollection 2014. PubMed PMID: 24940087; PubMed Central PMCID: PMC4051734. 2. Ledonio CG, Polly DW Jr, Vitale MG, Wang Q, Richards BS. Pediatric Pedicle Screws: Comparative Effectiveness and Safety: A Systematic Literature Review from the Scoliosis Research Society and the Pediatric Orthopaedic Society of North America Task Force. J Bone Joint Surg Am. 2011 Jul 6;93(13):1227-34. doi: 10.2106/JBJS.J.00678. Review. PubMed PMID: 21776576. 3. Emohare O, Ledonio CG, Hill BW, Davis RA, Polly DW Jr, Kang MM. Cost Savings Analysis of Intrawound Vancomycin Powder in Posterior Spinal Surgery. Spine J. 2014 Nov 1;14(11):2710-5. doi: 10.1016/ j.spinee.2014.03.011. Epub 2014 Mar 17. PubMed PMID: 24650851. 4. Lorio MP, Polly DW Jr, Ninkovic I, Ledonio CG, Hallas K, Andersson G. Utilization of Minimally Invasive Surgical Approach for Sacroiliac Joint Fusion in Surgeon Population of ISASS and SMISS Membership. Open Orthop J. 2014 Jan 24;8:1-6. doi: 0.2174/1874325001408010001. eCollection 2014. PubMed PMID: 24551025; PubMed Central PMCID: PMC3924210.

5. Ledonio CG, Polly DW Jr, Swiontkowski MF. Minimally Invasive Versus Open Sacroiliac Joint Fusion: Are They Similarly Safe and Effective? Clin Orthop Relat Res. 2014 Jun;472(6):1831-8. doi: 10.1007/s11999-014-3499-8. PubMed PMID: 24519569; PubMed Central PMCID: PMC4016421. 6. Larson AN, Polly DW Jr, Diamond B, Ledonio CG, Richards BS 3rd, Emans JB, Sucato DJ, Johnston CE. Minimize Implants Maximize Outcomes Study Group. Does Higher Anchor Density Result in Increased Curve Correction and Improved Clinical Outcomes in Adolescent Idiopathic Scoliosis? Spine (Phila Pa 1976). 2014 Apr 1;39(7):571-8. doi: 0.1097/BRS.0000000000000204. PubMed PMID: 24430717. 7. Yson SC, Sembrano JN, Sanders PC, Santos ER, Ledonio CG, Polly DW Jr. Comparison of Cranial Facet Joint Violation Rates Between Open and Percutaneous Pedicle Screw Placement Using Intraoperative 3-D CT (O-arm) Computer Navigation. Spine. 2013 Feb 15;38(4):E251-8. doi:10.1097/BRS.0b013e31827ecbf1. PubMed PMID: 23197012.

8. Larson AN, Polly DW Jr, Guidera KJ, Mielke CH, Santos ER, Ledonio CG, Sembrano JN. The Accuracy of Navigation and 3D Image-Guided Placement for the Placement of Pedicle Screws in Congenital Spine Deformity. J Pediatr Orthop. 2012 Sep.32(6):e23-9. doi: 10.1097/BPO.0b013e318263a39e. PubMed PMID: 22892631. 9. Sembrano JN, Polly DW Jr, Ledonio CG, Santos ER. Intraoperative 3-Dimensional Imaging (O-arm) for Assessment of Pedicle Screw Position: Does it Prevent Unacceptable Screw Placement? Int J Spine Surg. 2012 Dec 1;6:49-54. doi: 10.1016/j.ijsp.2011.11.002. eCollection 2012. PubMed PMID: 25694871; PubMed Central PMCID: PMC4300877.

10. Mehta H, Santos E, Ledonio CG, Sembrano J, Ellingson A, Pare P, Murrell B, Nuckley DJ. Biomechanical Analysis of Pedicle Screw Thread Differential Design in an Osteoporotic Cadaver Model. Clin Biomech (Bristol, Avon). 2012 March. 27(3):234-40. doi: 10.1016/j.clinbiomech.2011.10.004. Epub 2011 Nov 8. PubMed PMID: 22071427.

11. Crawford CH III, Ledonio CGT, Bess RS, Buchowski JM, Burton DC, Hu SS, Lonner BSH, Polly DW, Smith JS, Sanders JO. Current Evidence Regarding the Etiology, Prevalence, Natural History, and Prognosis of Pediatric Lumbar Spondylolysis: A Report from the Scoliosis Research Society Evidence-Based Medicine Committee. Spine Deformity. 2015;3(1):12-29.

12. Crawford CH III, Ledonio CGT, Bess RS, Buchowski JM, Burton DC, Hu SS, Lonner BSH, Polly DW, Smith JS, Sanders JO. Current Evidence Regarding the Surgical and Nonsurgical Treatment of Pediatric Lumbar Spondylolysis: A Report from the Scoliosis Research Society Evidence-Based Medicine Committee. Spine Deformity. 2015;3(1):30-44.

13. Larson AN, Aubin C-E, Polly DW, Jr Ledonio CGT, Lonner BS, Shah SA, Richards BS III, Erickson MA, Emans JB, Weinstein SL. Are More Screws Better? A Systematic Review of Anchor Density and Curve Correction in Adolescent Idiopathic Scoliosis. Spine Deformity. 2013;1(4):237-247. C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

14. Ledonio CGT, Polly DW, Jr Crawford CH III, Duval S, Smith JS, Buchowski JM, Yson SC, Larson AN, Sembrano JN, Santos ERG. Adult Degenerative Scoliosis Surgical Outcomes: A Systematic Review and Meta-analysis. Spine Deformity. 2013;1(4):248-258. 15. Sembrano JN, Yson SC, Polly DW Jr, Ledonio CG, Nuckley DJ, Santos ER. Comparison of Nonnavigated and 3-dimensional Image-Based Computer Navigated Balloon Kyphoplasty. Orthopedics. 2015 Jan;38(1):17-23. doi:10.3928/01477447-20150105-51. PubMed PMID: 25611407. 16. Luo TD, Polly DW Jr, Ledonio C, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years Using Navigation and Intraoperative CT. J Spinal Disord Tech. 2014 Dec 2. [Epub ahead of print] PubMed PMID: 25469494.

17. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Pediatric Pedicle Screw Placement Using Intraoperative Computed Tomography and 3-Dimensional Image-Guided Navigation. Spine

(Phila Pa 1976). 2012 Feb 1;37(3):E188-94. doi: 10.1097/BRS.0b013e31822a2e0a. PubMed PMID: 21738101. 18. Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. The Accuracy of Intraoperative O-Arm Images for the Assessment of Pedicle Screw Position. Spine. 2012 Jan 15; 37(2):E119-25. doi: 10.1097/ BRS.0b013e3182257cae. PubMed PMID: 21673628.

19. Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. Validity of Surgeon Pderception of Navigated Pedicle Screw Position: A Cadaveric Study. Spine. 2011 Jul 1;36(15):E1027-32. doi: 10.1097/ BRS.0b013e3181ff5b73. PubMed PMID: 21304435.

20. Collinet-Adler S, Castro CA, Ledonio CG, Bechtold JE, Tsukayama DT. Acinetobacter Baumannii is Not Associated With Osteomyelitis in a Rat Model: A Pilot Study. Clin Orthop Relat Res. 2011 Jan;469(1):274-82. doi: 10.1007/s11999-010-1488-0. Epub 2010 Jul 29. PubMed PMID: 20668970; PubMed Central PMCID: PMC3008889.

21. Polly DW Jr, Chou D, Sembrano JN, Ledonio CG, Tomita K. An Analysis of Decision Making and Treatment in Thoracolumbar Metastases. Spine. 2009 Oct 15;34(22 Suppl):S118-27. doi: 10.1097/BRS.0b013e3181ba6d02. Review. PubMed PMID: 19829271.

22. Ledonio CG, Arendt EA, Adams JE, Matz J, Boers A, Miller K, Lester BR. Reprocessed Arthroscopic Shavers: Evaluation of Sharpness and Function in a Cadaver Model. Orthopedics. 2014 Jan;37(1):e1-9. PubMed PMID: 24683649.

23. Hoel RJ, Ledonio CG, Takahashi T, Polly DW Jr. Sacral Bone Mineral Density (BMD) Assessment Using Opportunistic CT scans. J Orthop Res. 2016 Jul 8. doi:10.1002/jor.23362. [Epub ahead of print] PubMed PMID: 27391403.

24. Ledonio CG, Rosenstein BE, Polly DW Jr, Johnston CE, Regelmann WE, Nuckley DJ. Pulmonary Function Tests Correlated with Thoracic Volumes in Adolescentidiopathic Scoliosis. J Orthop Res. 2016 May 21. doi: 10.1002/ jor.23304. [Epub ahead of print] PubMed PMID: 27208463. 25. Floccari LV, Larson AN, Crawford CH III, Ledonio CG, Polly DW Jr, Carreon LY, Blakemore L, Minimize Implants Maximize Outcomes Study Group. Which Malpositioned Pedicle Screws Should Be Revised? J Pediatr Orthop. 2016 Apr 13.[Epub ahead of print] PubMed PMID: 27078232. 26. Luo TD, Polly DW Jr, Ledonio CG, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years or Younger Using Navigation and Intraoperative CT. Clin Spine Surg. 2016 Apr;29(3):E135-8. doi:10.1097/ BSD.0000000000000230. PubMed PMID: 27007788.

27. Wozniczka JK, Ledonio CG, Polly DW Jr, Rosenstein BE, Nuckley DJ. Adolescent Idiopathic Scoliosis Thoracic Volume Modeling: The Effect of Surgical Correction. J Pediatr Orthop. 2016 Feb 10. [Epub ahead of print] PubMed PMID: 26866643.

28. Garber T, Ledonio CG, Polly DW Jr. How Much Work Effort is Involved in Minimally Invasive Sacroiliac Joint Fusion? Int J Spine Surg. 2015 Nov 6;9:58. doi: 10.14444/2058. PubMed PMID: 26609513; PubMed Central PMCID: PMC4657608.

C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

29. Larson AN, Polly DW Jr, Ackerman SJ, Ledonio CG, Lonner BS, Shah SA, Emans JB, Richards BS 3rd; Minimize Implants Maximize Outcomes Study Group. What Would be the Annual Cost Savings if Fewer Screws Were Used in Adolescent Idiopathic Scoliosis Treatment in the US? J Neurosurg Spine. 2016 Jan;24(1):116-23. doi:10.3171/2015.4.SPINE131119. PubMed PMID: 26384134. 30. Sembrano JN, Yson SC, Polly DW Jr, Ledonio CG, Nuckley DJ, Santos ER. Comparison of Nonnavigated and 3-Dimensional Image-Based Computer Navigated Balloon Kyphoplasty. Orthopedics. 2015 Jan;38(1):17-23. doi:10.3928/01477447-20150105-51. PubMed PMID: 25611407. 31. Larson AN, Polly DW Jr, Diamond B, Ledonio C, Richards BS 3rd, Emans JB, Sucato DJ, Johnston CE. Minimize Implants Maximize Outcomes Study Group. Does Higher Anchor Density Result in Increased Curve Correction and Improved Clinical Outcomes in Adolescent Idiopathic Scoliosis? Spine (Phila Pa 1976). 2014 Apr 1;39(7):571- 8. doi: 10.1097/BRS.0000000000000204. PubMed PMID: 24430717. 1. Ledonio CT, Gomez VR. Application of Kuntcher Nail with Bone Cement for GCT of the Proximal Tibia A Case Report, Presented at Philippine Hip and Knee Society, Manila Midtown Hotel, 2000. 2. Ledonio CT, Rivera AA, Gustilo RB. Uncemeted Total Hip Arthroplasty in a 16 y/o after Girdle-Stone Procedure A Case Report. Poster Presentation, 52nd Philippine Orthopaedic Association Annual Convention, 2001. 3. C.T. Ledonio, MD; E.A. Sarrosa Graft Failure after ACL reconstruction: A Case Report, Presented at Philippine Hip and Knee Society, The New World Renaissance Hotel, October 2002, Poster Presentation, 53rd Philippine Orthopaedic Association Annual Convention, 2002.

4. Ledonio CT, Rivera AA. Closed Kinetic Chain Exercises After ACL Reconstruction: A Ten Year Follow-Up Study, Makati Medical Center Proceedings 2003-2004.

5. Ledonio CT, River AA. Bonifacio L. Profile of Soccer Injuries in the Finals of Philippine Football League, Paper Presentation, Philippine Orthopaedic Association Annual Convention, 2003. 6. Ledonio CT, Tacata IS. Predictors of Success of Open Carpal Tunnel Release Paper Presentation, Philippine Orthopaedic Association Annual Convention, 2003.

7. Ledonio CT. Motion Capture Technology and the Throwing Athlete Lecturer/Presenter, Spring Training Conference 2006, TRIA Orthopaedic Center, Minneapolis, MN

8. Braman JP, Ledonio CT, Graver RM. What Drives Costs? Profitability in the Ambulatory Surgery Center, Poster Presentation, AAOS Annual Meeting, 2007.

9. Ledonio CT, Swiontkowski MF. Sacroiliac Joint Fusion a Retrospective Study, Presented, Minnesota Orthopaedic Society Annual Meeting, 2007.

10. Ledonio CT, Swiontkowski MF. Anterior Approach to Sacroiliac Joint Arthrodesis, Presented, Minnesota Orthopaedic Society Annual Meeting, 2007 & Mid-America Orthopaedic Association Annual Meeting, 2008. 11. Polly DW, Sembrano JN, Ledonio CT. Intra-Articular Hip Pathology Diagnosed by MR Arthrography Among Patients With Low Back Pain, Poster Presentation, Spineweek, Geneva, Switzerland 2008. 12. Polly DW, Ledonio CT, et al. New Bone Formation in a Chronically-Infected Segmental Defect in the Rat Femur Treated with BMP-2 and Local Antibiotic, Poster and Short-Talk Poster, SOMOS 2008 and ORS 2009 respectively. 13. Tsukayama D, Ledonio CT, Polly DW, et al. Polymicrobial Chronic Infection Including Acinetobacter Baumannii in a Plated Segmental Defect in the Rat Femur, Podium presentation SOMOS 2008 and Poster presentation ORS 2009. 14. The Prevalence of Smokers in a Cohort of Patients being Considered for Spine Surgery Compared to State and National Prevalence: Ledonio, Polly, Johnson, Schellhas, Peltier, Perra, Schwender, Hatsukami (Presented at Minnesota Orthopaedic Society (MOS) annual meeting May 2009) C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

15. Validation of Surgeon Perception of Navigated Pedicle Screw Position: A Cadaveric Study: Ledonio, Santos, Sembrano, Truong, Castro, Nuckley, Polly (Presented at MOS annual meeting May 2009) 16. The Incidence Of Discography Resulting in Recommendations Against Lumbar Spinal Fusion: Ledonio, Polly, Johnson, Schellhas, Peltier, Perra, Schwender (Presented at MOS annual meeting May 2009) 17. Intervertebral Disc Volume Measurement for Pre-Surgical Planning Of Lumbar Interbody Fusion: A Pilot Study: Ledonio, Nuckley, Sembrano, Santos, Polly (Presented at MOS annual meeting May 2009) 18. The Use of Intraoperative 3D Ct Imaging for Pedicle Screw Placement In Patients With Or Without Coronal Spinal Deformity: Ledonio, Polly, Sembrano, Santos (Presented at MOS annual meeting May 2009; International Meeting on Advance Spine Techniques (IMAST) 2009; North American Spine Society 2009) 19. The Societal Perspective on Postoperative Spine Surgery Infections and Cost Shifting: Polly, Ledonio, Ondra, Shaffrey, Glassman (Presented at MOS annual meeting 2009 and IMAST 2009) 20. What is the Potential Value of a New Technology to Lessen the Rate of Re-Herniation after Lumbar Discectomy: Polly, Wong, Ledonio, Glassman

21. Sembrano JN, Yson SC, Polly DW Jr, Ledonio CG, Nuckley DJ. 3-D Image-Based Computer Navigation Reduces Needle Malposition Rates in Balloon Kyphoplasty: (Presented as E-poster IMAST 2010) 22. Charles Gerald T. Ledonio, David W. Polly, Zoher Ghogawala, Raja Y. Rampersaud, Edward Rainier G. Santos, Jonathan N. Sembrano, Sharon C. Yson, Societal Cost Impact of Decompression Alone Versus Decompression and Fusion for Degenerative Spondylolisthesis Spine J, 12(9), S125-S126 (2012) 23. Charles Gerald T. Ledonio, David W. Polly Jr., Sue Duval, Charles H. Crawford, Sharon C. Yson, A. Noelle Larson, Edward Rainier G. Santos, Jonathan N. Sembrano, Jacob M. Buchowski, Justin Smith, Meta-Analysis of Adult Degenerative Scoliosis Surgical Treatment Outcomes: Results of University of Minnesota and Scoliosis Research Society Evidence-Based Medicine Task Force Spine J, 12(9), S125 (2012) 24. Noelle Larson, David W. Polly, Beverly E. Diamond, T. Ledonio Charles Gerald, Daniel J. Sucato, Hubert Labelle, John Emans, B. Stephens Richards, Charles E. Johnston, Does Higher Screw Density Result in Increased Curve Correction and Improved Clinical Outcomes in Adolescent Idiopathic Scoliosis (AIS) Spine J, 12(9), S129 (2012) 25. Arin M. Ellingson, David W. Polly, Jutta Ellermann, T. Ledonio Charles Gerald, David J. Nuckley, Correlation of Intervertebral Disc T2* MRI Presentation with 3D Kinematics Spine J, 12(9), S59-S60 (2012) 26. Charles Gerald Ledonio, David Polly, Blake Johnson, The Efficacy of Epidural Steroid Injection (ESI) in Smokers

& Non-Smokers with Leg and/or Back Pain Spine J, 11(10), S44 (2011) 27. David W. Polly, Charles G. T. Ledonio, Michael G. Vitale, B. Stephens Richards, Meta-Analysis of the Safety and Efficacy of Pedicle Screw Spinal Instrumentation in Pediatric Spinal Deformity: Results of SRS and POSNA Task Force Spine J, 10(9), S4-S5 (2010)

28. Charles G. T. Ledonio, Alex Hendricks, Edward R. G. Santos, Jonathan N. Sembrano, David J. Nuckley, David W. Polly, Intra-Operative Feedback for Lumbar Interbody Fusion: Intervertebral Disc Volume Removal and Outcomes Spine J, 10(9), S48-S49 (2010)

29. Edward Rainier G. Santos, Jonathan N. Sembrano, Carlos Castro, Charles Ledonio, Walter Truong, David W. Polly, Accuracy of Intra-operative O-arm Images in Determining Pedicle Screw Position Spine J, 10(9), S50

(2010)

30. Edward Rainier G. Santos, Jonathan N. Sembrano, Charles T. Ledonio, Carlos Castro, Walter Truong, David W. Polly, Validation of Surgeon Perception of Navigated Pedicle Screw Position: A Cadaveric Study Spine J, 10

(9), S78 (2010)

31. David Polly, Charles Ledonio, Christopher Shaffrey, Steven Glassman, P41. The Societal Perspective on Postoperative Spine Surgery Infections and Cost Shifting Spine J, 9(10), 135S (2009) C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, ඈ, MD, CCRP RP

32. David Polly, Charles Ledonio, Jonathan Sembrano, Edward Rainier Santos, 124. The Use of Intraoperative 3D CT Imaging for Pedicle Screw Placement in Patients with or without Coronal Spinal Deformity Spine J, 9(10), 64S-65S (2009)

33. Charles Ledonio, David Polly, Blake Johnson, Kurt Schellhas, James Schwender, Carrie Peltier, Joseph Perra, 16. The Incidence of Discography Resulting in Recommendations Against Lumbar Spinal Fusion Spine J, 9(10), 8S-9S (2009)

34. Charles Gerald T. Ledonio, David W. Polly, Ann M. Brearley, A. Noelle Larson, Daniel J. Sucato, Alvin Crawford, Leah Y. Carreon, David A. Stevenson, Michael G. Vitale, Christopher L. Moertel, Neurofibromatosis Type I and Scoliosis: A Multicenter Study to Determine Radiographic Predictors of Dystrophic Scoliosis Spine J, 13(9), S117

(2013)

35. David W. Polly, Ben Rosenstein, Charles Gerald T. Ledonio, Charles E. Johnston, David J. Nuckley, Thoracic Volume Predicts Pulmonary Function Recovery in Scoliosis Patients Spine J, 13(9), S37 (2013) 36. Charles Gerald T. Ledonio, David W. Polly, Ann M. Brearley, A. Noelle Larson, Daniel J. Sucato, Leah Y. Carreon, Alvin Crawford, David A. Stevenson, Michael G. Vitale, Christopher L. Moertel, Neurofibromatosis Type 1 and Dystrophic Scoliosis: A Multicenter Study of Accuracy of Surgeons’ Radiographic Assessment Spine J, 13

(9), S59 (2013)

37. Charles Gerald T. Ledonio, David W. Polly, Ben Rosenstein, A. Noelle Larson, Modeling Thoracic Volume for Adolescent Idiopathic Scoliosis Spine J, 13(9), S111-S112 (2013) 38. Matson DM, Ledonio C, Polly DW, Jr., England K, Pawelek J, Akbarnia BA. Paper #39 (ICEOS): Thoracic Volume Modeling of Growing Spine Interventions in Early-Onset Scoliosis. Spine Deformity. 2014;2(6):514. Title: Genetic Evaluation of Scoliosis Gene in Patients with Neurofibromatosis Type 1 and Scoliosis - PI: David W. Polly, Jr., MD

Time Commitments: Role: Co-Investigator/Project Manager with 50% effort Designed methodology and protocol; responsible for day to day activities, patient recruitment, data management, regulatory maintenance, annual reports, data analysis, drafting abstracts and manuscripts.

Supporting Agency: Department of Defense thru Congressionally Directed Medical Research Program, Neurofibromatosis Research Program

Performance Period: 2010 - 2015

Level of Funding: $716,000 (Contract #W81XWH-10-1-0469) Brief Project’s Goals: The long range goal of this study is to possibly develop a genetic test in NF1 patients with scoliosis that is predictive of dystrophic, or non-dystrophic type. The short term goal for the proposal is to see if the non-dystrophic curves have the same SNPs as in AIS and if these SNPs are prognostic.

Specific Aims: 1. Development and validation of a grading scheme to classify dystrophic changes in patients with NF1 scoliosis.

2. Perform genetic testing on patients with NF1 who have had clinical treatment for scoliosis. Although the NF1 gene has been identified, no specific genetic markers have been identified in NF1 patients with scoliosis. Genetic evaluation on a known group of NF1 patients with scoliosis will allow us to gain insight as to which phenotypes of NF1 patients would possibly develop spine deformities.

C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

Title: Minimizing Implants Maximizing Outcome Clinical Trial Time Commitments: Role: Project Manager/Co-Investigator with 20% effort Co-wrote research design plan methodology and protocol and pre-award documentations. Responsible for day to day activities, patient randomization, data management, regulatory maintenance, annual reports, data analysis, drafting abstracts and manuscripts. Supporting Agency: Orthopaedic Research Educational Foundation Performance Period: June 1, 2012 – May 31, 2016

Level of Funding: $281,000

Brief Project’s Goals: This is a prospective, multicenter randomized controlled trial to determine clinical and radiographic equivalence of a high-density versus low-density patterns for scoliosis deformity correction to improve the effectiveness and safety of scoliosis surgery. Specific Aims: 1. Prospectively enroll and randomize adolescent idiopathic scoliosis patients (Lenke 1 and 2, curves 45 to 65 degrees) to a low-versus high-density pedicle screw construct to determine if there is a clinically significant difference between the two groups in percent Cobb correction, sagittal plane alignment, and patient-reported outcome scores. 2. Develop a data management center, train and establish sites for the proposed randomized controlled trial, test and disseminate an educational module for patient recruitment and retention.

3. Evaluate the 3D deformity associated with each curve pre-operatively and post-operatively to determine expected coronal, rotational, and axial plane correction from a low-versus high-pedicle screw density pattern.

Title: Biomechanical Study Examining the S2 Alar Iliac Screw Time Commitments: Role: Principal Investigator with 20% effort Responsible for overall project including: patient recruitment and consent, data management, regulatory maintenance, annual reports, data analysis, writing reports, abstracts and manuscripts for publication.

Supporting Agency: Applied Research Division Medtronic Spinal and Biologics Performance Period: 2012 – 2015

Level of Funding: $17,388

Brief Project’s Goals: The objective of this project is to measure the intraoperative torque required to place an iliac screw for fixation of long lumbar spinal fusions. This fixation method often results in variable screw fixation strength and an improved understanding of the local torques required along the length of the screw will aid in improving this surgical fixation. Specific Aims: This proposed research will examine the intraoperative insertion torque for iliac screw insertion for long lumbosacral fusions. Provide a data set describing the biomechanics of screw insertion in an in vivo human surgical situation.

Title: Quantitative Thoracic Volume Modeling of Growing Spine Interventions Time Commitments: Role: Co-Investigator/Project Manager with 20% effort Responsible for day to day activities, computerized thoracic volume modeling, data management, regulatory maintenance, annual reports, data analysis, writing abstracts and manuscripts for publication.

Supporting Agency: Chest Wall and Spine Deformity Foundation Performance Period: 2013 - 2014

Level of Funding: $24,570 (CWSD0053)

Brief Project’s Goals: The goals of surgical intervention of early onset scoliosis in the growing spine are to provide deformity correction, prevent progression while allowing growth of the spine and thorax, prevent pulmonary function compromise by providing adequate thoracic volume and maintain trunk growth. The causal relationship between spine/chest wall deformity and pulmonary function has yet to be fully defined. The specific hypothesis behind the proposed research is that deformity correction improves pulmonary function by restoring both respiratory muscle efficiency and increasing the space available to the lungs.

Specific Aims: Determine the change in thoracic volume before and after scoliosis correction. We will show significant volumetric change when comparing initial and final correction. As the process of growing spine correction lasts for several months, we will be using 8 time points reflected in the appropriate radiographic sets in order to evaluate change in thoracic volume of 10-20 individuals. Thoracic volume will be measured on AP & Lateral x-rays of the entire thoracic compartment. Thoracic volume change of each time point will be evaluated using open source Blender software and validated computer aided algorithm developed by U of MN Spine research team. C ൺඋඅൾඌ Gൾඋൺඅൽ Tൺඇ Lൾൽඈඇ ඈ, MD, CCRP RP

Title: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Adolescent Idiopathic Scoliosis Time Commitments: Role: Subaward Recipient/Co-Investigator/Project Management with 20% effort Responsible for day to day activities and patient specific computerized modeling and de-identification.

Supporting Agency: Scoliosis Research Society – Mayo Clinic Performance Period: 2012 - 2014

Level of Funding: $8,750

Brief Project’s Goals: The aim of this subcontract is to assess chest wall volumetric changes based upon radiographs to determine the 3D changes in the chest volume before and after treatment for scoliosis. These chest volume measurements will be correlated with treatment, quality of life scores

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