Message From The President

Dear Friends,

We are proud to share with you the accomplishments of Setting Scoliosis Straight during the most challenging year we have all faced. Despite the COVID-19 pandemic, the patients we serve continue to need our expertise. Scoliosis progression knows nothing about social distancing… We certainly had to pivot several times this past year, and in the end many of our goals were realized. New discoveries that change lives continue whether we meet virtually or in person. The same committed physicians, researchers, staff and volunteers got the work done, thank you all.

Our online educational content for patients continues to grow and we have partnered with the Food and Drug Administration to gather input from our patients on what’s important to them as they navigate their journey in life with scoliosis. We appreciate the partnership and look forward to bringing those additional research studies and additional collaborations to you all soon.

Thank you again for your ongoing and continued support of our mission.

Peter Newton, MD
President, Setting Scoliosis Straight

Message From The Executive Director

Dear Scoliosis Family,

In reflecting on the persistent state of chaos that encompassed 2020, I am filled with pride and gratitude for the unwavering resilience of our team and research sites. Their ability to quickly pivot to maintain research data collection enabled the successful continuation of our multicenter studies despite obstacles presented by the pandemic. Sadly, we were unable to celebrate the 25th anniversary of the Harms Study Group in New York as scheduled in 2020. However, we experienced many positive developments, including the launch of our Non-Fusion research, and new collaborations with surgeons, industry partners, and the FDA.

Our Patient Education efforts shifted from in-person to virtual settings and our educational video content expanded significantly. We remain committed to improving the lives of patients with scoliosis and look forward to the next 25 years!

Michelle Marks, PT, MA
Executive Director, Setting Scoliosis Straight

The Non Profit Foundation

The Setting Scoliosis Straight Foundation (SSSF) is a not-for-profit charitable foundation established in 2008 to support the research efforts of the Harms Study Group. The Foundation focuses on fundraising, awareness, patient education and improving quality in care.

Board of Directors

Members of Setting Scoliosis Straight’s board of directors are all uniquely connected to spinal deformities. This diverse group of individuals volunteers their time, expertise, and energy, to ensure the foundation is successful in fulfilling its mission.

Peter Newton, MD

President & Chairman

Dr. Newton is currently Chief of Scoliosis and Orthopedic Research at Rady Children’s Hospital in San Diego, while serving as Clinical Professor of Orthopaedic Surgery in the Department of Orthopedic Surgery at the University of California, San Diego. He resides in San Diego, CA and joined the board in 2008

David Clements, MD

Vice President

Dr. Clements is currently Director of the Spine and Scoliosis Service at Cooper Bone & Joint Institute, New Jersey, while serving as Professor of Orthopaedic Surgery and Neurosurgery, Cooper Medical School of Rowan University and is an Attending Surgeon, Shriner’s Hospital for Children, Philadelphia Unit. He resides in Merion Station, PA and joined the board in 2011.

Michelle Marks, PT, MA

Secretary & Executive Director

Michelle is the Research Director of the HSG research organization and the Executive Director of the Setting Scoliosis Straight Foundation, where she manages a team of twelve. he is a current associate member of the Scoliosis Research Society, serving on the Research Grant and Program Committees. She resides in San Diego, CA and joined the board in 2008.

Robert Stone, CPA

Treasurer

Robert joined the board in January 2012 and has served on multiple committees, his involvement however, dates all the way back to 1986. Robert also serves on the Board of Trustees for Mount Sinai Medical Center, Mount Sinai Foundation, and Ransom Everglades School in Coral Gables, Florida, where Robert resides with his family.

“Congratulations to HSG on their Silver anniversary of their founding. The accomplishments are amazing. More amazing accomplishments are on the horizon , given the involvement with the non-fusion studies just beginning. Only the best wishes for the future of HSG.”

~ Harry Shufflebarger, MD

Harry Shufflebarger, MD

Board Member

Dr. Shufflebarger is currently at Paley Orthopedic and Spine Institute while serving as Clinical Professor, Department of Orthopedics & Rehabilitation at the University of Miami. He was the President of the Scoliosis Research Society in 1999 and presently serves on the IMAST Program Committee. He resides in Florida and joined the board in 2008.

Randal Betz, MD

Board Member

Dr. Betz is currently Emeritus Chief of Staff and Medical Director of Research at Shiners Hospitals for Children in Philadelphia while serving as Professor of Orthopedic Surgery at Temple University School of Medicine. He resides in Ocean City, New Jersey and joined the board in 2008.

Tom Errico, MD

Board Member

Dr. Errico is a currently Chief of Division of Spine at NYU Hospital for Joint Disease, as well as the Director of Spine Fellowship and Director of Spine Center for Musculoskeletal Care at NYU HJD. He is a tenured Professor of Orthopedic and Neurological Surgery in the NYU School of Medicine. He resides in New York City and joined the board in 2012.

Lawrence Lenke, MD

Board Member

Dr. Lenke is a Jerome J. Gilden Distinguished Professor of Orthopedic Surgery the Chief of Spine Surgery, and Co-Chief of Adult/Pediatric Spinal Deformity Surgery at Washington University School of Medicine. He was President of the Scoliosis Research Society in 2011.

Baron Lonner, MD

Board Member

Dr. Lonner is currently serving as director of Scoliosis and Spine Associates and the Spinal Deformity Center at the NYU Hospital for Joint Diseases in New York, and he is a Clinical Professor of Orthopaedic Surgery at NYU. He resides in New York City and joined the board in 2011.

Amer Samdani, MD

Board Member

Dr. Samdani is currently Chief of Surgery at the Shriner’s Hospital for Children in Philadelphia. He completed his neurosurgery training at Johns Hopkins Medical School with a Chief Residency at Johns Hopkins Hospital followed by Fellowship training at Cornell University in New York and at the Children’s Hospital of Philadelphia. He resides in Philadelphia and joined the board in 2008.

“In my 20 years as an industry partner to the foundation, I have always been incredibly moved hearing stories from patients and their families and the impact surgery had on their lives. I too had a life changing orthopedic procedure when I was a child, and to now be a part of the foundation is an incredible honor. I am truly humbled to be serving on the board to help continue the great work of advancing patient care.”

~ Ross Sylvia

Suken Shah, MD

Board Member

Dr. Shah is currently Division Chief of the Spine and Scoliosis Service and Clinical Fellowship Director at the Nemours/Alfred I. DuPont Hospital for Children in Wilmington, Delaware, while serving as Associate Professor of Orthopaedic Surgery at Thomas Jefferson University in Philadelphia, Pennsylvania. He resides in Wilmington, Delaware and joined the board in 2011.

Kevin Sayar, Esq.

Board Member

Kevin is co-founder and President at ebrary, the preferred e-book provider to institutions and researchers worldwide. Kevin’s ten-year–old daughter, Emma, recently underwent fusionless surgical treatment for Scoliosis and he is committed to assisting the mission of the Setting Scoliosis Straight Foundation. He resides in Los Altos, California and joined the board in 2013.

Stacey Goldfarb, Esq.

Board Member

Stacey is a lawyer, a mother of two, and a Board Member on the Setting Scoliosis Straight Board of Directors. Stacey joined the board in 2014, and she brought with her the perspective of a patient, a commitment to letting other patients know that there is light at the end of the tunnel, and an outlook of pure gratitude.

Firoz Miyanji, MD

Board Member

Dr. Miyanji is a Clinical Professor at the University of British Columbia, Department of Orthopedics whose clinical practice focuses on pediatric spinal deformity at British Columbia Children’s Hospital. He completed a combined Orthopedic and Neurosurgical adult spine fellowship at the Toronto Western Krembil Neurosciences Center followed by an additional fellowship in Pediatric Orthopedics and Scoliosis at Rady Children’s Hospital in San Diego.

Bo Jamieson

Board Member

With 35 years in spine Bo has been a key relationship builder liaising between spine surgeons and the Company to evolve procedures and partnerships to deliver the optimal deformity patient care. Bo is originally from the Cleveland Ohio area, and currently resides in Denver and Pasadena with his wife Linda and their dog Vincent.

Ross Sylvia

Board Member

Ross has spent 20 years as an executive within the healthcare industry – the majority of which has been related to spinal deformity, where he has led the development of some of the worlds leading implant systems, as well as supported numerous research, educational and patient advocacy initiatives.

Emma Sayar

Emmatisse was 9 years old when she discovered she had scoliosis. She was diagnosed with a 51 degree thoracic curve. Emmatisse had her scoliosis treated with Vertebral Body Tethering (VBT) to correct her curve. Although she had a few setbacks with her treatment, she keeps a smile on her face and remains focused on creating awareness of scoliosis and raising funds for scoliosis research.

Emmatisse recently held the largest single person fundraiser to benefit Setting Scoliosis Straight. She raised over $1,900.

Alyssa Holtrust

We are excited to introduce our new Scoliosis Ambassador, Alyssa Holtrust (White Shirt). Alyssa was diagnosed with scoliosis when she was 15 years old. But that didn’t stop her from dancing! Alyssa had reached out to SSS to start a fundraiser. She has done an amazing job organizing a successful dance class called, “Dance For a Cause” to fundraise for scoliosis research.

Alyssa fundraiser raised $650.oo. We cannot thank her enough for her amazing support!

Charlee Fraser

Charlee Fraser was diagnosed with scoliosis when she was 14 years old. But that didn’t stop her from pursuing her dream of becoming a model! Today, she is an Indigenous Australian international supermodel that has scoliosis. Charlee has walked the catwalk for some of the most famous designers and graced the covers of Vogue, Harper’s Bazaar, Marie Claire, and many more. She has represented and starred in several major designer cosmetic, eyewear, and designer clothing ad campaigns.

Thank you, Charlee for all your time and support that you have given us!

Rachel Lian

“I was diagnosed with Adolescent Idiopathic Scoliosis in 2013, when I was 12 years old. Although my spine had been straight less than a year earlier at my annual physical appointment, I suddenly had a curvature of over 50 degrees. It seemed as though my entire world came crumbling down. As a teenager, this diagnosis made self-acceptance seem impossible. At the same time, as a dancer, tennis player, and musician, it was difficult to think about not being able to continue these beloved hobbies.”

>>>Click Here to Read Rachel’s Full Story

Scoliosis Patients Giving Back

The girls, Sydney, Talia, Chloe, and Amanda, who range in age from middle school to high school, have all undergone spinal fusion surgery to correct scoliosis. The girls met through their doctor who connected them with each other so they could share their experiences. Once the girls got to talking, they came up with the idea to gather information from other patients and create a booklet that helps others who are about to have surgery.

Spinal Fusion Surgery - Helpful Tips Booklet-2

New Spinal Fusion Surgery Booklet

The booklet was developed to address how to prepare for surgery and what to expect after surgery to help make the journey through spinal fusion surgery a little bit easier on the patients and their families.

Visit our website to learn how you can get your hands on this booklet.

Webinars in 2020

Setting Scoliosis Straight has hosted an in-patient education course, called POWER OVER SCOLIOSIS in various US cities since 2016.

Due to COVID-19, we were forced to cancel this event in 2020. This pandemic has challenged us in many ways, but that didn’t stop us from educating patients and their families.

Since we all have been spending a lot of time at home this year, we decided to hold several webinars to educate and provide expert insight to patients and their families. Some of these webinars included patients sharing their experiences and offering advice to newly diagnosed patients.

A big Thank You to all of the doctors and patients that participated.

Visit our website to see what

we have in store for 2021!

Scoliosis Educational Videos

The Setting Scoliosis Straight is proud to present our large video library which consists of evidence-based information explained in animated infographics and a wide range of interviews with renowned surgeons and patients who have traveled through different treatments.

Visit our YouTube Channel to view all our educational videos

The Research Group

Founded in 1995, the Harms Study Group (HSG) is a collaborative group of surgeons who perform comprehensive, multi-center, prospective research studies focused on pediatric and adolescent spinal deformities. This Research Study Group is dedicated to answering important clinical questions regarding treatment approaches, techniques, and best practices. All research is performed with the ultimate goal of improving patient outcomes.

2020 Scientific Presentations & Publications

As most scientific annual meetings were shifted to Virtual Events due to COVID-19, HSG scientific presentations were reduced this year. The HSG had 2 Poster Presentations and 2 Podium Presentations at International Meeting on Advanced Spine Techniques (IMAST) and 6 Poster Presentations and 14 Podium Presentations at Scoliosis Research Society (SRS).

To see all of our Publications, click on the button below to download our 2020 Annual Report PDF.

Click Here

Cerebral Palsy (CP) Scoliosis Study

Grateful acknowledgement to our sole sponsor of this research study: Stryker Spine, Inc.

Leading the charge for this study is primary investigator, Paul Sponseller, MD, who is the Chief of the Division of Pediatric Orthopaedics at Johns Hopkins Children’s Center. Dr. Sponseller has been a member of the Harms Study Group since 2004.

CP Research Discoveries in 2020

Patrick Cahill, MD

Dr. Cahill studied Prolonged Post-Operative Intubation Following Spinal Fusion in Cerebral Palsy. He determined three Risk Factors: preoperative Body Mass Index, history of pneumonia and intra-operative blood loss for prolonged intubation and demonstrated that prolonged intubation is associated with numerous additional peri-operative medical complications.

Dr. Cahill also evaluated the Impact of Spinal Deformity and Surgery on Health-Related Quality of Life in Cerebral Palsy. In this prospective longitudinal cohort study of scoliosis associated with cerebral palsy, he reported that health related quality of life (HRQoL) was improved at 24 months for patients who underwent a spinal fusion compared to a nonoperative control group.

Burt Yaszay, MD

With Dr. Yaszay’s research effort he asked the clinical question, “Does the upper instrumented vertebrae have to be T2 in CP Patients Undergoing Spinal Fusion for their Neuromuscular Scoliosis?” He found that outcomes between patients fused to the second thoracic vertebrae (T2) (the “gold standard”) vs patients fused to the third or fourth Thoracic vertebrae (T3/T4) resulted in similar radiographic and clinical outcomes.

Suken Shah, MD

Dr. Shah performed a matched cohort study to compare severe CP scoliosis patients treated with anterior release and PSF versus PSF alone. He found that patients treated with anterior release demonstrated decreased curve correction on flexibility radiographs, correcting less than 30%. Patients treated with anterior release had similar postoperative scoliosis and pelvic obliquity correction, but experienced longer hospital stays and increased complications. In severe CP scoliosis, despite the associated morbidity, anterior release may still be indicated in curves demonstrating less than 30% flexibility.

Dr. Shah also evaluated Proximal Junctional Kyphosis (PJK) After Spinal Deformity Correction in Cerebral Palsy and found that 12.8% of patients developed PJK and 8% underwent reoperation. Patients with PJK were more likely to be hyperkyphotic preop and without severe cognitive impairment. PJK does have a negative effect on patient reported outcomes.

Idiopathic Scoliosis (IS) Study

We are extremely grateful for the longstanding support from the primary sponsor of this research effort, DePuy Synthes Spine, Inc. In addition, we are thankful for the support from adjunct sponsors of this study: NuVasive, Stryker, Inc., and EOS Imaging.

Dr. Peter Newton remains at the helm of this study as the primary investigator. This database registry is the largest, highest quality, comprehensive, longitudinal series of operative outcomes in Idiopathic Scoliosis.

IS Research Discoveries in 2020

Larry Lenke, MD

Dr. Lenke evaluated Selective vs. Non-Selective Thoracic Fusion for Lenke Type 1-4C Curves, to determine which has More Complications at 5-Year Follow-up. Selective thoracic fusion is associated with lower short- and long-term complications compared to non-selective thoracic fusion. It did not increase the rate of reoperation rate for residual lumbar deformity.

Steven Hwang, MD

3D imaging has improved our understanding of rotation in AIS surgery and allows us to better measure surgical derotation achieved. Dr. Hwang, sought to determine if single or dual rod derotation is associated with greater apical derotation. He compared 452 patients with Lenke 1-4 curves, and found 73.1% of patients achieved > 50% improvement in apical rotation or thoracic rib prominence. Greater pre-op rotation and institutionspecific factors were most predictive of improvement in apical rotation. Single vs dual rod derotation, metal type, implant density, osteotomies, and other radiographic variables were not associated with greater correction.

Nick Fletcher, MD

Dr. Fletcher analyzed patients treated with a selective fusion where the lowest instrumented vertebrae was proximal to the stable sagittal vertebrae. In these patients, he found a 15% incidence of DJK at five years of postoperative follow up compared to 2.2% of patients fused distal to the SSV. Surgeons should take the stable sagittal vertebrae into account when planning selective thoracic fusion to avoid DJK and the possibility of revision surgery..

Amit Jain, MD

There is substantial variability in the use of bone grafts and substitutes within this large cohort of AIS patients who underwent spinal fusion in our HSG Idiopathic Scoliosis database registry. Dr. Jain evaluated the use of bone graft substitutes or extenders (BS) in spinal fusion surgery and found they did not reduce the rate of reoperation or pseudarthrosis. However, the use of bone graft substitutes or extenders was associated with higher incidence of wound related complications.

Scoliosis Non-Fusion Research Studies

The Harms Study Group is currently conducting research on “Retrospective Multi-Center Study of the Outcomes of Anterior Vertebral Body Tethering for Spinal Deformity Correction” lead by Peter Newton, MD.

This study currently has 11 international sites participating, >300 patients’ data included, and will have post-operative data collected up to 8 years following surgery.

Scoliosis Non-Fusion Research Studies

Our second Non-Fusion study titled, “Non Fusion Spinal Deformity Correction in Idiopathic Scoliosis – A Prospective, Multi-Center Registry Study of the Harms Study Group” is lead by Amer Samdani, MD.

This study currently has 15 international sites participating, annual planned enrollment of >150 patients, and will have post-operative data collected up to 25 years post-operatively.

Scoliosis Non-Fusion Research Studies

The Harms Study Group is also assisting Zimmer Biomet in conducting their HDE POST APPROVAL STUDY.

The Tethering – Vertebral Body Tethering System Post Approval Study.

This study currently has 10 U.S. sites participating, 200 patients followed for 5 years postoperatively, and FDA required for device approval compliance.

FDA Collaboration

Survey Study to understand patient preferences surrounding spine surgery

Since 2012, the FDA has been soliciting proposals to advance the state of the art within various areas through a specialized contract mechanism known as FDA’s Broad Agency Announcement (BAA).

In 2020, the FDA awarded a 5 year research contract (BAA) to the Harms Study Group. Research scientists at the FDA, Mayo Clinic and Duke University are collaborating to administer a patient preference survey that will be used to understand patient preferences in scoliosis treatment, specifically fusion versus non-fusion surgical treatment approaches.

- Primary Investigators: Noelle Larson, MD & Baron Lonner, MD
- 7 participating research sites.
- 525 surveys to be collected from Pediatric Idiopathic Scoliosis patients.

The results of this patient preferences survey will provide the FDA, industry and clinicians with crucial data regarding how patients and families value various factors including preservation of spinal motion and growth when deciding among surgical treatment options for pediatric idiopathic scoliosis.

Picture of FDA staff members exhibiting at 2019 Power Over Scoliosis in Philadelphia:

From left to right: David Gebben, PhD, Heather Benz (former staff member), PhD, Vincent J. Devlin, MD,

Elizabeth Adegboyega-Panox, MD, CAPT Raquel Peat, PhD, MPH, USPHS

Development of a Shared-Decision Making Tool

As the second part of the FDA contract, the Mayo Clinic Shared Decision Making National Resource Center will assist SSS and HSG to develop and test a Shared Decision Making tool (decision aid) to be used with patients and families considering fusion surgery vs. motion sparing growth modulation surgery.

Video acquisition of 40 ‘usual care’ consultation visits between patients and surgeons in which scoliosis treatment options of fusion surgery vs. motion sparing growth modulation surgery are discussed.

The recordings will then be observed by Mayo Clinic Knowledge Evaluation Research (KER) Unit in Rochester, MN, led by Dr. Victor Montori and Dr. Juan Brito Campana.

2020
Fiscal Year

Revenue & Support

Industry Research Study Sponsors, Donors & All Income

Download our 2020 Annual Report PDF to view the full sponsors and donors list.

Download PDF

Sponsorships and Special Events did not occur in 2020 due to the Pandemic.

Financial Report

Functional Expenses

85% of every dollar we receive goes directly to OUR MISSION and OUR COMMITMENT to improving countless children’s lives.

Surgeon Performance Program

The Setting Scoliosis Straight Surgeon Performance Program is a quality improvement initiative designed for orthopedic surgeons to help optimize performance and improve patient outcomes in the treatment of Idiopathic Scoliosis, Neuromuscular Scoliosis & Pediatric Spondylolisthesis. Through participation in this quality improvement registry and routine dashboard reporting, surgeons can evaluate their performances and advance patient care.

The Surgeon Performance Program has been approved by the American Board of Orthopaedic Surgery (ABOS) Maintenance of Certification (MOC) Committee as an alternate choice for earning self-assessment examination (SAE) credits for the Board’s MOC process.

The program is featured in US News & World Report’s survey for ranking pediatric hospitals! We are honored for this recognition as we continuously strive to enhance our quality improvement efforts and promote optimal patient care on a global scale.

Visit our SPP website for more information!

Learn More

2020 HSG Accomplishments

Dr. Suken Shah was presented with the Russell A. Hibbs Clinical Research Award for his research entitled, “Complications following posterior surgical treatment of Adolescent Idiopathic Scoliosis: Prospective 10-year Follow-up Study” at the annual Scoliosis Research Society Meeting.

CONGRATULATIONS DR. SHAH!

2020 HSG Accomplishments

Dr. Burt Yaszay was bestowed with the Louis A. Goldstein Clinical Research award for his e-Poster: “Definitve Fusions are Better than Growth Friendly Procedure for Juvenile Patients with Cerebral Palsy and Scoliosis: A Prospective Comparative Cohort Study” at the annual Scoliosis Research Society Meeting.

WELL DONE DR. YASZAY!

2020 HSG Accomplishments

Dr. Firoz Miyanji’s abstract entitled, “Vertebral Body Tethering: Truly Motion Preserving or Rather Motion Limiting?” and Michelle Marks’s abstract entitled, “Does a Surgeon’s Performance and patient outcomes improve with Dashboard Reporting?” were both nominated for

Message From The President

Dear Friends,

Thank you again for your ongoing and continued support of our mission.

Peter Newton, MD President, Setting Scoliosis Straight

Message From The Executive Director

Dear Scoliosis Family,

Our Patient Education efforts shifted from in-person to virtual settings and our educational video content expanded significantly. We remain committed to improving the lives of patients with scoliosis and look forward to the next 25 years!

Michelle Marks, PT, MA Executive Director, Setting Scoliosis Straight

The Non Profit Foundation

The Setting Scoliosis Straight Foundation (SSSF) is a not-for-profit charitable foundation established in 2008 to support the research efforts of the Harms Study Group. The Foundation focuses on fundraising, awareness, patient education and improving quality in care.

Board of Directors

Members of Setting Scoliosis Straight’s board of directors are all uniquely connected to spinal deformities. This diverse group of individuals volunteers their time, expertise, and energy, to ensure the foundation is successful in fulfilling its mission.

“Congratulations to HSG on their Silver anniversary of their founding. The accomplishments are amazing. More amazing accomplishments are on the horizon , given the involvement with the non-fusion studies just beginning. Only the best wishes for the future of HSG.”

~ Harry Shufflebarger, MD

~ Ross Sylvia

Emma Sayar

Emmatisse recently held the largest single person fundraiser to benefit Setting Scoliosis Straight. She raised over $1,900.

Alyssa Holtrust

Alyssa fundraiser raised $650.oo. We cannot thank her enough for her amazing support!

Charlee Fraser

Thank you, Charlee for all your time and support that you have given us!

Rachel Lian

Scoliosis Patients Giving Back

New Spinal Fusion Surgery Booklet

The booklet was developed to address how to prepare for surgery and what to expect after surgery to help make the journey through spinal fusion surgery a little bit easier on the patients and their families.

Visit our website to learn how you can get your hands on this booklet.

Webinars in 2020

Setting Scoliosis Straight has hosted an in-patient education course, called POWER OVER SCOLIOSIS in various US cities since 2016.

Due to COVID-19, we were forced to cancel this event in 2020. This pandemic has challenged us in many ways, but that didn’t stop us from educating patients and their families.

Since we all have been spending a lot of time at home this year, we decided to hold several webinars to educate and provide expert insight to patients and their families. Some of these webinars included patients sharing their experiences and offering advice to newly diagnosed patients.

A big Thank You to all of the doctors and patients that participated.

Visit our website to see what

we have in store for 2021!

Scoliosis Educational Videos

The Setting Scoliosis Straight is proud to present our large video library which consists of evidence-based information explained in animated infographics and a wide range of interviews with renowned surgeons and patients who have traveled through different treatments.

Visit our YouTube Channel to view all our educational videos

The Research Group

2020 Scientific Presentations & Publications

To see all of our Publications, click on the button below to download our 2020 Annual Report PDF.

Cerebral Palsy (CP) Scoliosis Study

Grateful acknowledgement to our sole sponsor of this research study: Stryker Spine, Inc.

Leading the charge for this study is primary investigator, Paul Sponseller, MD, who is the Chief of the Division of Pediatric Orthopaedics at Johns Hopkins Children’s Center. Dr. Sponseller has been a member of the Harms Study Group since 2004.

CP Research Discoveries in 2020

Patrick Cahill, MD

Burt Yaszay, MD

Suken Shah, MD

Idiopathic Scoliosis (IS) Study

We are extremely grateful for the longstanding support from the primary sponsor of this research effort, DePuy Synthes Spine, Inc. In addition, we are thankful for the support from adjunct sponsors of this study: NuVasive, Stryker, Inc., and EOS Imaging.

Dr. Peter Newton remains at the helm of this study as the primary investigator. This database registry is the largest, highest quality, comprehensive, longitudinal series of operative outcomes in Idiopathic Scoliosis.

IS Research Discoveries in 2020

Larry Lenke, MD

Steven Hwang, MD

Nick Fletcher, MD

Amit Jain, MD

Scoliosis Non-Fusion Research Studies

The Harms Study Group is currently conducting research on “Retrospective Multi-Center Study of the Outcomes of Anterior Vertebral Body Tethering for Spinal Deformity Correction” lead by Peter Newton, MD.

This study currently has 11 international sites participating, >300 patients’ data included, and will have post-operative data collected up to 8 years following surgery.

Scoliosis Non-Fusion Research Studies

Our second Non-Fusion study titled, “Non Fusion Spinal Deformity Correction in Idiopathic Scoliosis – A Prospective, Multi-Center Registry Study of the Harms Study Group” is lead by Amer Samdani, MD.

This study currently has 15 international sites participating, annual planned enrollment of >150 patients, and will have post-operative data collected up to 25 years post-operatively.

Scoliosis Non-Fusion Research Studies

The Harms Study Group is also assisting Zimmer Biomet in conducting their HDE POST APPROVAL STUDY.

The Tethering – Vertebral Body Tethering System Post Approval Study.

This study currently has 10 U.S. sites participating, 200 patients followed for 5 years postoperatively, and FDA required for device approval compliance.

FDA Collaboration

Survey Study to understand patient preferences surrounding spine surgery

Since 2012, the FDA has been soliciting proposals to advance the state of the art within various areas through a specialized contract mechanism known as FDA’s Broad Agency Announcement (BAA).

Primary Investigators: Noelle Larson, MD & Baron Lonner, MD

7 participating research sites.

525 surveys to be collected from Pediatric Idiopathic Scoliosis patients.

Development of a Shared-Decision Making Tool

Video acquisition of 40 ‘usual care’ consultation visits between patients and surgeons in which scoliosis treatment options of fusion surgery vs. motion sparing growth modulation surgery are discussed.

The recordings will then be observed by Mayo Clinic Knowledge Evaluation Research (KER) Unit in Rochester, MN, led by Dr. Victor Montori and Dr. Juan Brito Campana.

2020 Fiscal Year

Revenue & Support

Industry Research Study Sponsors, Donors & All Income

Download our 2020 Annual Report PDF to view the full sponsors and donors list.

Financial Report

Functional Expenses

85% of every dollar we receive goes directly to OUR MISSION and OUR COMMITMENT to improving countless children’s lives.

Peter Newton, MD
President, Setting Scoliosis Straight

Michelle Marks, PT, MA
Executive Director, Setting Scoliosis Straight

2020
Fiscal Year