Principal Investigators
Michael O’Brien, M.D., Medical Director of Research
Richard Hostin, Jr., M.D., Medical Director
Clinical Research Coordinators
Chantelle M. Freeman, B.S., Research Manager
Erin McCullough, B.S., Research Coordinator
Background:
The Baylor Scoliosis Center is committed to advanced research efforts designed to improve the treatment and quality of life of all spine deformity patients. With outstanding innovations and breakthrough results, the BaylorScoliosisCenter aspires to reach thousands of patients and their families. As a result of such exceptional research efforts, the work of the Baylor Scoliosis Center has been presented at several international conferences including the International Meeting on Advanced Spine Techniques, the North American Spine Society, and the Scoliosis Research Society. In the past year alone, several abstracts relating to the areas of surgical technique, fusion, instrumentation and surgical outcomes have been presented to audiences which have included renowned deformity surgeons worldwide. Currently, research in the areas of pain, spine fusion, and genetics are being investigated.
Progressive studies in the area of geneticsare at the forefront of clinical investigations at the Baylor Scoliosis Center. Much information can be gained from studying scoliosis at the cellular level. Through the research efforts of the Baylor Scoliosis Center, Axial Biotech in collaboration with DePuy Spine, Inc. was able to develop the ScoliScore™, a prognostic assay which can predict, with extreme accuracy, an adolescent’s chance of a developing a severe scoliotic curve. With information gained by researching scoliosis at the genetic level and by studying cellular activity, physicians at the Baylor Scoliosis Center will be able to pioneer unprecedented treatment techniques.
Studies in pain, spine fusion, and genetics are simply the foundation on which to build an ever robust research establishment at the Baylor Scoliosis Center. Its physicians and researchers are committed to providing gold standard investigations which will contribute to enhanced and superior treatment of spine deformity patients. Current research has already been recognized by other spine surgeons internationally. With persistent effort, research being conducted at the BaylorScoliosisCenter will continue to be acknowledged. Most importantly, patients that are treated here will continue to get the best in care as a result of such stellar research efforts.
Current Studies and Projects:
- Baylor Scoliosis Center Electronic Research Database:
Since its inception in August 2008, the Baylor Scoliosis Center research database has over 2506 completed research questionnaires from Baylor Scoliosis Center patients and over 1200 additional scheduled research questionnaires. In addition, there is data for over 1200 scoliosis surgical patients. This data includes basic patient history and physical information, surgical information;health related quality of life (HRQL) questionnaire results, as well as radiographic data.
- AxialBiotech Scoliosis Genetic Marker Study:
Progressive studies in the area of genetics are at the forefront of clinical investigations at the Baylor Scoliosis Center. Much information can be gained from studying scoliosis at the cellular level. This area of scoliosis has not been previously studied in depth. Researchers at the Baylor Scoliosis Center are excited about chartering unknown territory by investigating genetic and cellular clues which may give better insight into the nature of scoliosis. With information gained by researching scoliosis at the genetic level and by studying cellular activity, physicians at the Baylor Scoliosis Center will be able to pioneer unprecedented treatment techniques. Currently, this project has over 220 enrolled subjects with an anticipated total of 500 subjects. Results from data to date have resulted in a genetic prognostic assay, the ScoliScore™, which with a large degree of certainty; can accurately predict the potential for curve progression in adolescent idiopathic scoliosis patients.
- ScoliScore™ AIS Prognostic Test:
The ScoliScore™ is the first, clinically validated and highly accurate prognostic test developed to predict the likelihood that a curve will not progress to a severe curve by skeletal maturity. It is a saliva based genetic test that analyzes the 53 progression markers associated with scoliosis. The ScoliScore™ is indicated for use in patients diagnosed with adolescent idiopathic scoliosis (AIS), Caucasian (North American, South American, European, Eastern European, Middle Eastern) males and females ages 9-13 with a mild curve of 10-25 degrees. Currently, the test is not indicated for Hispanics, Africans, African-Americans and Asians. However, ongoing research is being performed (the Genetic Marker Study) in an effort to include these groups in the future.
- DePuySpine HEALOS® Study:
One major complication which may result from spine deformity surgery is called Pseudoarthrosis, or non-union of the vertebrae. This condition may cause additional pain in scoliosis surgical patients and may result in an additional surgery. The HEALOS® Study is being conducted to evaluate the efficacy of fusion for surgical patients after a biologic material is placed in the spine during surgery and is used to aid the natural bone healing process. Patients are evaluated postoperatively at a minimum of one year using computed tomography (CT scan) and reports from the CT scan and physician evaluations will be a useful means toward improved surgical technique and overall healing for scoliosis surgical patients. Currently, this study is closed to enrollment and researchers are in the process of writing a manuscript detailing the results of this study.
- Health Economics Cost Analysis Study:
Adult spinal deformity can run the gamut from simple to complex. Most adult spinal deformities can be categorized into four groups: 1) primary idiopathic, 2) primary degenerative, 3) primary sagittal plane deformity, and 4) revisions. These etiologies can result in scoliosis, kyphosis, or a combination thereof. Generally, treatment for these conditions is straightforward, but may require a significant surgery to undertake and accomplish a successful reconstruction. The success or the outcome from these procedures may be variable due to complications encountered either intra-operatively or per-operatively. Depending on the extent of the surgical intervention, the patient’s co-morbidities and the presence of major and minor complications may significantly alter the effectiveness and the cost of taking care of these patients. The purpose of this study is to evaluate the four diagnostic categories of adult deformity and analyze the results of surgery within these diagnostic categories form a complications, outcomes and cost point of view.
- CSSG Multi-Center Retrospective and Observational Clinical and Radiographic Data Registry (beginning 2nd quarter FY012):
This is a multi-center/multi-surgeon electronic data capture registry that includes retrospective surgical case data with a minimum patient follow up of two years post surgery. The purpose of the registry is to compile medical and surgical data into a common deformity registry from multiple spine deformity sites in order to more comprehensively describe the course of spinal deformity and/or potentially identify correlations that may predict progression. The registry will also attempt to help stratify the effectiveness of various treatment modes, which may lead to a better understanding of the course and nature of spinal deformity.
International Spine Study Group:
- Prospective Operative vs. Non Operative Study:
Compared to adolescent idiopathic scoliosis, operative treatment of adult scoliosis is associated with higher complication rates, prolonged recovery time, and greater economic cost. Postoperative outcomes are often compromised by complications and revision surgery. Consequently, physicians must carefully weigh the risk/benefit ratio when deciding upon operative or non operative treatment of adult scoliosis. There is little data currently available that considers age stratification of adult deformity patients treated operatively versus non operatively and followed over a period of time as regards to clinical and radiographic outcomes. To date, no guidelines exist to stratify or score the risk benefit ration that will produce an algorithm for treatment. This study is closed to enrollment and is currently in the data collection and study patient follow up phase.
- Risk Stratification /Proximal Junctional Kyphosis Retrospective Study:
Adult spinal deformity encompasses abnormal alignment of the spine involving coronal, sagittal or biplane deformity (e.g. scoliosis, kyphosis, flatback syndrome). The causes of spinal deformity are multifold. Some deformities are idiopathic with superimposed degenerative changes, and others are de novo lumbar curves. Treatment recommendations differ for adult and childhood spinal deformities. Adolescent idiopathic scoliosis is most often painless, and surgical intervention is warranted due to curve severity and risk progression. However, adult deformity treatment is often guided by pain and disability secondary to their condition which drives the need for surgical intervention. A risk scoring system will permit better comparisons of outcomes between studies and centers. Additionally, healthcare providers can benefit in payor negotiations for complex and high risk cases and hospitals can ensure appropriate cost comparisons based upon complexity in terms of procedure as well as risk.
The proximal junctional kyphosis arm is an extension to the risk stratification study and will attempt to answer questions regarding the high rate of proximal Junctional failure in spine deformity patients. The hypothesis is that an increased risk of early proximal junctional failure in adult spinal deformity constructs can be identified based on the predicted impact of reciprocal regional alignment changes and bone density data. Analysis will included alterations in sagittal vertical alignment (SVA), alterations in sagittal and coronal Cobb angle, changes in sagittal angulations from horizontal upper instrumented vertebra (UVA), analysis of spinopelvic parameters, and analysis of available bone mineral density data as well as type of spinal implants used. Patients from each International Spine Study Group site are included in this study.
- ISSG Medical Economics Pilot Study (beginning second quarter FY012):
To date, there is little cost effectiveness analysis that exists with regards to various treatment modalities for adult spinal deformity. The purpose of this pilot study is to evaluate the disease burden associated with adult spinal deformity from a quality adjusted life year perspective and to evaluate the cost effectives of non operative treatment for adult spinal deformity.
AcademicPresentations:
2007
DepuySpine, Inc., Chicago, IL,June 2, 2007
Posterior Osteotomy for Rigid Scoliosis in the Adult Spine
Minimally Invasive Surgeries, Deformity Spine Study Group, Virginia, July 27, 2007 MIS: A Single Case Study of Superiorly Positioned Instrumentation
DePuySpine, Inc., CME-based Roundtable, Dallas, TX, September 12, 2007
Bone Grafting Options for Spinal Fusion
2008
DePuySpine, Inc., Biologics Presentation, Dallas, TX, January 2008
The Science of Bone Grafting: Clinical Experience with the Cellect System
Neurosurgeon Deformity Symposium, Phoenix, AZ, April 11, 2008
Spinal Osteotomy for Treating Rigid Deformity in the Adult Spine
DePuySpine, Inc., National Training Meeting, Las Vegas, NV, April 18-19, 2008
“Straighten Your Strategy” Case Presentation: Dual Innie Interlocking System
AAOS/SRS Course, Dallas, TX, May 16-17, 2008
Management of Spondylolysis and Spondylolisthesis
DePuySpine Adult Deformity Tutorial, Baylor Regional Medical Center at Plano, November 2008
Surgical Challenges in Adult Spinal Deformities
Infection Management and the Cost of Treatment
2010
DePuySpine Advanced Techniques Symposium, Osaka, Japan, September 2010
Medical Grand Rounds, Baylor Regional Medical Center at Plano, September 2010
Complex Spinal Deformity: Current Principles for Release, Realignment, and Instrumentation
2011
International Meeting on Advanced Spine Techniques, Copenhagen, Denmark, July 2011 – Principles and Practice in the Treatment of Adult Kyphosis
International Meeting on Advanced Spine Techniques, Copenhagen, Denmark, July 2011 –
Moderator: Optimal Treatment for a 10mm Mobile Degenerative L4-L5 Spondylolisthesis in a 75-Year Old
Oral and Poster Presentations
2007
Review of Screw Strategies for Cervical Spine Fixation. Podium presentation:International Meeting of Advanced Spine Techniques (IMAST), Paradise Island, Bahamas, July 2007
Outcomes of Pedicle Subtraction Osteotomies for Fixed Sagittal Imbalance. E-poster;
International Meeting of Advanced Spine Techniques (IMAST), Paradise Island, Bahamas, July 2007. E-poster: North American Spine Society (NASS), October 2007
Complications of Pedicle Subtraction Osteotomy. Podium presentation:North American Spine Society (NASS), Austin, Texas, October 2007
2008
Mechanical DVT Prophylaxis and Ultrasound Screening Are Not Effective in Preventing Pulmonary Embolism in Adult Spinal Deformity Surgery. E-poster presentation: International Meeting on Advanced Spine Techniques (IMAST), Hong Kong, China, July 2008. Podium presentation: North American Spine Society (NASS), Toronto, Canada, October 2008.
2009
Evaluation of Bone Marrow Aspirate vs. Bone Morphogenetic Protein (rhBMP-2) in Multilevel Adult Spinal Deformity Surgery: Minimum Two-Year Evaluation of Anterior Fusion Rates and Clinical Outcomes. Paper and podium presentation: Scoliosis Research Society. San Antonio, TX 2009
The Use of Scoliosis Research Society Outcome Scores and Oswestry Disability Index as an Indicator of Pseudoarthrosis in Adult Spinal Deformity: Can Outcome Questionnaires Predict Need for Revision? E-poster presentation: Scoliosis Research Society. San Antonio, TX 2009. E-poster presentation: International Meeting on Advanced Spine Techniques. Vienna, Austria 2009
An Analysis of 161 Consecutive Anterior or Anterior Lateral Lumbar Interbody Fusions in Adult Spinal Deformity: Standard Posterior Anterior and Lateral Radiographs Are Not Sufficient for Identifying Pseudoarthrosis. E-poster presentation: International Meeting of Advanced Spine Techniques. Vienna, Austria 2009
2010
Treatment Parameters and Injury Mechanisms Associated with Acute Proximal Junctional Failure Following Posterior Spinal Fusion for Deformity. E-poster presentation: International Meeting on Advanced Spine Techniques. Toronto, Canada 2010. E-poster presentation: North American Spine Society. Orlando, FL 2010 (ISSG)
Acute Proximal Junctional Failure Following Long Posterior Fusion for Spinal Deformity: Risk Factors and Radiographic Analysis Comparing Thoracolumbar to Upper Thoracic Failures. Podium presentation: International Meeting of Advanced Spine Techniques. Toronto, Canada 2010. E-poster presentation: North American Spine Society. Orlando, FL 2010 (ISSG)
2011
Mineralized Collagen and Bone Marrow Aspirate in Anterior Interbody Carbon Fiber Cages Achieves High Fusion Rates in Multilevel Adult Spinal Deformity Surgery. E-poster presentation: International Meeting on Advanced Spine Techniques. Copenhagen, Denmark, July 2011. Digital poster: Congress of Neurological Surgeons. Washington, DC, October 2011.
Preliminary Analysis of Direct Cost for Four Diagnostic Categories of Adult Spinal Deformity (ASD). Podium presentation: Scoliosis Research Society. Louisville, KY, September 2011. Neurosurgical forum: Congress of Neurological Surgeons. Washington, DC, October 2011.
Other Studies in Collaboration with the International Spine Study Group (ISSG):
2009
Patients Perceive Perioperative Complications as More Severe and Having Greater Negative Consequences than Surgeons. Traditional Poster: International Meeting on Advanced Spine Techniques. Vienna, Austria 2009. Traditional poster: Scoliosis Research Society. San Antonio, TX 2009. E-poster presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
Extension of Previous Fusions to the Sacro-Pelvis vs. Primary Spino-Pelvic Fusions in the Setting of adult Deformity: A Comparison of Health Related Quality of Life Measures and Complications.Traditional poster: Scoliosis Research Society. San Antonio, TX 2009. E-poster presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
Outcomes and Complications of Extension of Previous Long Fusion to the Sacro-Pelvis: Does Surgical Approach Make a Difference? Podium presentation: Scoliosis Research Society. San Antonio, TX 2009. Podium presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
The Impact of Reciprocal Regional Alignment Changes Distant from the Site of Spinal Osteotomies Affects Post-Operative Spinal Balance. Podium presentation: International Meeting on Advanced Spine Techniques. Vienna, Austria 2009. Traditional poster presentation: Scoliosis Research Society. San Antonio, TX 2009. E-poster presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
PSO Failures can be Predicted by High Pre-Op SVA and Pelvic Tilt. Podium presentation: Scoliosis Research Society. San Antonio, TX 2009. Podium presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
Pre-Operative Pelvic Parameters Must be Considered to Achieve Adequate Sagittal Balance After Lumbar Osteotomy. Podium presentation: International Meeting on Advanced Spine Techniques. Vienna, Austria 2009. Traditional poster: Scoliosis Research Society. San Antonio, TX 2009. E-poster presentation: North American Spine Society. San Francisco, CA 2009. Oral poster presentation: Congress on Neurological Sciences. New Orleans, LA 2009.
Major Complications Following Adult Spinal Deformity Surgery: Is There A High Risk Patient Profile? Podium presentation: International Meeting on Advanced Spine Techniques. Vienna, Austria 2009. Traditional poster: Scoliosis Research Society. San Antonio, TX 2009. Podium presentation (Top Ten*): Congress on Neurological Sciences. New Orleans, LA 2009.
2010
Thoracic Pedicle Subtraction Osteotomy for Adult Spinal Deformity Improves Regional Spinal Deformity and Pelvic Tilt. Podium presentation: Scoliosis Research Society. Kyoto, Japan 2010. Oral poster presentation: North American Spine Society. Orlando, FL 2010.
Common Mathematical Formulas Fail to Predict Postoperative Sagittal Alignment: Confirmation of a Need for More Advanced Equations. Podium presentation: International Meeting on Advanced Spine Techniques. Toronto, Canada 2010. Traditional poster: Scoliosis Research Society. Kyoto, Japan 2010. Podium presentation: North American Spine Society. Orlando, FL 2010.
Risk Factors for Major Peri-operative Complications in Adult Spinal Deformity Surgery: A Multi-center Review of 953 Consecutive Patients. Podium presentation: Scoliosis Research Society. Kyoto, Japan 2010. Oral poster presentation: North American Spine Society. Orlando, FL 2010.Podium presentation: American Association of Neurological Surgeons. Denver, CO, April 2011.