Our objective is to be internationally recognized for the highest quality published research on pediatric and adolescent spinal deformity treatment outcomes.
The Harms Study Group (HSG) is a collaborative cohort of worldwide distinguished surgeons dedicated to the advancement of treatment for children and adolescents with spine deformity. Through comprehensive, multicenter prospective research studies, questions regarding treatment approach and techniques to achieve desired outcomes are studied with a commitment to be internationally recognized for the highest quality published research on new spinal deformity treatment outcomes.
The presence of this study group at national meetings and in the literature is without comparison. Through current (and past) membership, the HSG has produced hundreds of podium presentations on adolescent spinal deformity at annual meetings and peer-reviewed journal articles and book chapters. Current surgeon members of the HSG include several members of the board of directors as well as three past presidents of the Scoliosis Research Society.
The development and maintenance of a strong infrastructure and a robust database system has been the key to this group’s success. This infrastructure consists of personnel with expertise in multi-center research study coordination, protocol development and implementation, database design and management (data verification and quality assurance practices), statistical analysis and interpretation, as well as expertise in contracting and budget management.
The HSG is dedicated to advancing the techniques used to analyze treatment outcomes and has implemented radiographic digital scanning procedures and digital image acquisition in all study group sites to enable central digital radiographic measuring capabilities. The group has begun to lead the field in utilizing three-dimensional radiographic measures in their research of spinal deformities. Collaborations with software and hardware companies for these goals are currently underway. All data entered in the central, web-based database undergoes central data quality assurance evaluation before it is utilized in our data queries.
The Setting Scoliosis Straight Foundation and The Harms Study Group work together to support discoveries, and advance techniques, in the treatment of spinal deformities in children and adolescents worldwide.
Through parent education, physician education, and multi-center clinical research, we provide the latest education on spinal deformity treatment and surgical treatment techniques to patients, patient families, surgeons, and healthcare providers.
Through high quality research, we plan to create a future where children and adolescents with spinal deformity will have the ability to live healthy, happy, and productive lives.
For the past decade, the Harms Study Group has been internationally recognized for producing the highest quality published research on new spinal deformity surgery techniques and treatment outcomes. The group has had over 180 peer reviewed publications in scientific journals. The group has achieved this standard by conducting comprehensive, multi-center prospective research studies aimed at answering important clinical questions regarding treatment approach and techniques.
It all began in 1995
The HSG was established in 1995 under the direction of Professor Jüregen Harms and Randal Betz with initial funding from Mr. Lutz Beidermann. The group began their initial study protocols and radiographic development.
In 1996, study sites were established and initial data collection was underway. Annual study group meetings occured for continued planning and development of the study group.
In 1997, the data collection was underway for the comparison of Anterior to Posterior fusion approach for scoliosis deformity correction. Initial manuscripts were published on outcomes of Anterior Instrumentation for Thoracic Idiopathic Scoliosis. Initial development of the Lenke Classification System was established.
Additional sites were included in the multi-center research efforts on the outcomes of surgical deformity correction in Adolescent Idiopathic Scoliosis. The initial manuscript for the Lenke classification system was published on the Intraobserver and interobserver reliability of the classification of thoracic adolescent idiopathic scoliosis.
In 1999, the SRS Questionnaire outcomes instrument was developed and published by Tom Haher, MD, a member of the Harms Study Group.
The results of the multi-center comparison of Anterior and Posterior instrumentation were published.
In 2000, formal multi-center study group funding was received from DePuy Orthopaedics. Peter Newton, MD and Randal Betz, MD developed the multi-user, web-driven scoliosis database. AIS multi-center research study protocols were formalized and the Lenke 1 study (comparing three surgical approaches for primary thoracic scoliosis) was launched. Harry Shufflebarger, MD, a Harms Study Group member, served as President of the Scoliosis Research Society.
With the new database in place, digital images of radiographs and clinical photographs were incorporated into the dataset. The AIS database volume became the largest in existence. The Lenke Classification was published: “Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis” in Journal of Bone and Joint Surgery. Alvin Crawford, MD, a Harms Study Group member, served as President of the Scoliosis Research Society.
The study group continued to grow and develop with the implementation of standardized data collection practices and the organized dissemination of individual member database mining projects. Administration of the study group was co-managed by the Philadelphia and San Diego sites. Research surgeons grew from 12 to 16 members.
Extensive database upgrades were completed for the multi-center study management. The San Diego site assumed the main administrative tasks of the study group. By 2003, the Study Group had produced over 30 peer-reviewed publications.
In 2004, the first multicenter retrospective study of Scheuermann’s Kyphosis was completed and the Prospective study of Scheuermann’s Kyphosis was launched with funding from DePuy Spine. Three multicenter retrospective studies were underway:
1. The use of Single Lung Ventilation
2. Retrospective CP Scoliosis
3. The Results of Three Classes of Surgical Treatment for Congenital Scoliosis Due to Hemivertebrae
In 2005, The Harms Study Group celebrated its 10th anniversary!
Randall Betz, MD, founding member of the Harms Study Group served as President of the Scoliosis Research Society, and at the SRS annual meeting, the Retrospective Multi-Center Kyphosis Study results were presented as a podium presentation. Results of Thoracoscopic Anterior fusion outcomes were published in Spine.
The retrospective study comparing ‘severe cases of scoliosis either treated with or without Halo Traction’ was implemented and surgeons outside of the HSG participated in this multicenter research effort.
The HSG also embarked on the development of a medical textbook project relating to the treatment of Idiopathic Scoliosis. The prospective study of motion preservation following spinal fusion was launched with funding from DePuy Spine, Inc.
The HSG central infrastructure was formalized with centralized digital x-ray measurement and storage, data organization and analysis for individual study group member projects, and data quality assurance for all prospective studies. The productivity of the group grew to 15 podium presentations presented at annual scientific meetings during the year. The “Lenke 1 Curve Study” was completed and the “Algorithm Study” was converted into a long-term Database Registry of AIS, in which operative and non-operative cases are included, with post-operative follow-up spanning twenty-five years. The results of the Multi-Center retrospective study of Kyphosis were published in Spine.
In 2008, the conversion of all existing manual x-ray measurements to digital measurements was initiated. The Retrospective Study of Posterior Vertebral Column Resection in Pediatric Spinal Deformity was successfully completed. The Prospective Study of Scoliosis in Children with Cerebral Palsy was launched with initial funding from DePuy Spine and became the second largest prospective multi-center research effort of the Harms Study Group, with Paul Sponseller, MD, serving as primary investigator of the study.
The Harms Study Group Foundation, a non-profit 501(c)(3) corporation, was formed to support the research efforts of The Harms Study Group.
In 2009, the Harms Study Group infrastructure focused on migrating the AIS data from the original database application into the improved version of the multi-user web-based database and continued converting all manual x-ray measurements into digital measurements. The study group began a new retrospective study on scoliosis correction in Marfan Syndrome. Peter Newton, MD publishes the ‘The Deformity-Flexibility Quotient’ in Spine.
In 2010, the surgeon members of the HSG completed the textbook, Idiopathic Scoliosis: The Harms Study Group Guide to Evaluation and Treatment and it was published by Thieme Publishers. Publications evaluating the Sagittal plane in AIS from the HSG start to highlight the considerations of the 3D deformity and the importance of Kyphosis restoration. A research grant is awarded to new investigator, Michelle Marks, PT, MA from the Scoliosis Research Society to study 10 year outcomes of postoperative motion in the unfused distal segments of the spine.
In 2011, the study group’s AIS Database Registry grew to over 3000 patients – the largest prospective series of surgical outcomes of AIS in existence. A grant from the Orthopedic Research and Education Foundation (OREF) was received for the Cerebral Palsy in Scoliosis study, allowing for future funding of this study through 2012. Lawrence Lenke, MD, a Harms Study Group member, served as President of the Scoliosis Research Society.
The Patient handbook, Adolescent Idiopathic Scoliosis: Navigating Your Journey–A Guide for You and Your Family was published.
In 2012, the members of the HSG conducted a Cerebral Palsy Scoliosis meeting, made possible by the grant awarded by the OREF. The patient education handbook was translated into Chinese and Spanish. The productivity of the study group soared to twenty-three podium presentations and twenty-seven poster presentations at scientific meetings. Annual surgeon metric dashboard reporting was implemented in the HSG.
The HSG prospective study of Scheuermann’s Kyphosis was completed and proved surgery for Scheuermann’s Kyphosis results in significant improvements in pulmonary function and Health Related Quality of Life. The prospective study of Post-Operative Motion in AIS, for patients with two to five year follow-up was completed. The study group’s productivity increased to 22 podium presentations at annual scientific meetings.
In 2014, the Patient-Based Research Initiative was established, aimed at developing research studies based on specific questions that are important to patients with scoliosis. The research productivity increased to 29 podium presentations at annual scientific meetings. The 3D evaluation of AIS revealed the loss of thoracic kyphosis in the sagittal profile.
In 2015, the Harms Study Group celebrated its 20th anniversary and the group’s excellence in research for two decades was celebrated at a Gala in Las Vegas. K2M assumed the role of the new sole sponsor of the Cerebral Palsy in Scoliosis study, which was converted into an ongoing registry study. Surgeon members of the Harms Study Group participated as faculty in the surgeon education course, Evidence-Based Pediatric Spinal Deformity Care.
EOS Imaging collaborated with the Harms Study Group to support the 3D reconstructions of AIS patients enrolled in the prospective multicenter study. The research productivity of the study group members increased to 37 podium presentations at annual scientific meetings.
The Surgeon Performance Program was developed highlighting an AIS Quality Improvement registry with funding from Medtronic and NuVasive. Surgeon participation will begin in September.
More Updates Coming Soon!