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Displaying items by tag: genetic testing
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An Interview with Dr. James Ogilvie, Past President of the Scoliosis Research Society, and Founder & Chief Medical Advisor for Axial BioTech, the Creators of the ScoliScore™ Genetic Prognostic Test for Scoliosis
Dr. James Ogilvie is a board-certified orthopaedic surgeon. In addition to private practice, Dr. Ogilvie is adjunct Professor, Department of Orthopaedic Surgery, at the University of Utah in Salt Lake City and Professor Emeritus, Department of Orthopaedic Surgery, at the University of Minnesota in Minneapolis, MN. He is Staff Surgeon / Attending Staff at Shriners Hospital Intermountain Unit in Salt Lake City.
He is an active member of many prestigious organizations including the Academic Orthopaedic Society, American Academy of Orthopaedic Surgeons, Scoliosis Research Society, and Society of Military Orthopaedic Surgeons. Dr. Ogilvie served as a Commander in the United States Naval Reserve.
CI: Please tell us about the ScoliScore™ prognostic test for scoliosis. What led you to create this test, and how do you feel it will impact the way scoliosis is managed today?
James Ogilvie MD: Our initial goal was to identify the 85% of children with mild adolescent idiopathic scoliosis (AIS) who would not progress to the surgical range untreated. The current standard is to monitor everyone with multiple clinic visits and x-rays which are both expensive and present the danger of radiation exposure to growing children.
CI: Is the ScoliScore™ test expensive? Does it hurt? How accurate is it?
JO: The DNA-based test is less expensive than other comparable genetic tests and costs $2950. Our patient assistance program means that unless someone is wealthy they seldom have an out of pocket expense. It is less expensive than unnecessary years of doctor visits and x-rays. It’s a saliva-based test (no blood drawing required), and has been clinically validated to be 98% accurate. For those with a risk score of less than 50 there is less than 1% probability of progression. We have no cases of progression with scores less than 30. There is a caveat that sometimes a misdiagnosis is present and a patient's curve may progress. An MRI is then indicated and we have instances of syringomyelia or other conditions that cause progressive spine deformity.
CI: One of the reasons we at CLEAR Institute are so excited about the ScoliScore™ test is because of the potential it offers for a more efficient, personalized system of scoliosis treatment. What do you feel are some of the problems with the current system of how scoliosis is managed?
JO: The current clinical guidelines cannot identify progressive from non-progressive AIS. DNA testing allows a personalized risk of progression that is unique to each patient.
CI: You’ve published dozens of important research articles in very well-recognized journals. In one of your recent scientific articles, you utilized the potential of the ScoliScore™ test to determine which patients were at a high risk for progression, and compared two groups of patients - braced & non-braced. Your conclusion was that there is no significant difference in the natural history of scoliosis between the two groups. Could you share with us your thoughts about how this study is different than any other study which has been done on bracing in the past? Did the results of this study surprise you?
JO: Rigid bracing has been commonly practiced by spine surgeons for more than 100 years. Unfortunately those studies were unable to risk stratify the enrolled patients. Therefore they observed some that had a high risk of progression and braced some that had less than 1% risk of progression. No definitive answers have come from the current brace studies. Many surgeons have suspected this was the case, but bracing had become the “standard of care” and it was too threatening not to brace young patients.
CI: We’ve heard a great deal about the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) study that is currently being led by Stuart Weinstein, MD, at the University of Iowa, which is the largest NIH-funded clinical trial in the history of orthopaedic pediatrics, and is scheduled for completion this August. What are your thoughts about this study? Do you think patients benefit from bracing?
JO: Without a knowledge of an individual patient’s risk of progression, some patients with little risk are being braced unnecessarily and some who have a very high risk are assigned to the observation arm. In effect, there is one equation with two unknowns, treatment assignment and genetic risk of progression. A single equation with two unknowns cannot be answered.
CI: The roots of bracing as a treatment for scoliosis go back a long ways (as early as 650 AD, Paul of Aegina was bracing scoliosis patients with wooden strips & bandages). What do you see happening in the future for scoliosis braces?
JO: With an understanding of the genetic factors that influence AIS progression and identify an individual’s risk, future spine therapists can challenge the current ineffective treatment routines and innovate on new therapies.
CI: If bracing is found not to be effective, do you think school scoliosis screening programs for scoliosis should be eliminated? How do you think ScoliScore™ will affect the potential benefit of scoliosis screening programs?
JO: Current school screening is not effective. However, early screening in school or a doctor’s visit is necessary to diagnosis AIS in its early stages when non-surgical treatments are more effective.
CI: Many people believe there are barriers to integrated medicine – that is, traditional medicine working hand-in-hand with alternative treatments such as chiropractic. Your presence here today is proof that hope exists for doctors of all specialties to work together for the common good of the patient, and it is greatly appreciated! What do you recognize as the major obstacles that prevent orthopedic surgeons from referring patients with mild scoliosis to a chiropractor?
JO: Health science is not the province of only one discipline. Allopathic medicine is ideally evidence-based. Surgeons will refer appropriate patients to the chiropractic profession, much as we refer patients to orthotists, as scientific evidence is generated that validates non-surgical treatment.
CI: Last March, some of the members of CLEAR Institute, including the founder, Dr. Dennis Woggon, were invited to the headquarters of Axial BioTech in Salt Lake City, Utah, for an opportunity to learn more about the ScoliScore™ test and tour the $19-million dollar facility in person. It made a very positive impression on everyone from CLEAR, and we would like to thank you again for Axial’s warm hospitality at that meeting. It was also an occasion for you to learn more about the methods & protocols developed by CLEAR Institute. What did you think about this new system of scoliosis treatment? Did anything in particular about CLEAR Institute impress you?
JO: I was impressed with two items, first the innovative approach that CLEAR has taken to non-operative AIS treatment is needed. With a realization that bracing is at best not very successful and at worst, not useful at all, innovative physiologic treatment regimes are needed. Secondly, CLEAR has made a commitment to evaluate these new therapies in a manner that will pass scientific scrutiny.
CI: The potential of the ScoliScore™ test to revolutionize research into scoliosis is amazing. For the first time in history, we have a method of identifying which patients are most likely to progress to surgical levels. In your opinion, is it possible that an individual at high risk could undergo a treatment which reduces their chance of progression? In other words, could it be possible to re-test someone after treatment and see a lower ScoliScore™ test result?
JO: It would be unlikely that the human genome will be changed by physical treatments. However, the expression of those genes can be modified.
CI: Dr. Ogilvie, thank you again for donating your time to share your knowledge & wisdom. Do you have any final words for our readers?
JO: DNA prognostic testing is only the beginning of our understanding of AIS genetics. As we learn what those causative genes do we may have even more effective interventions. Thank you for your generosity in letting me introduce genetic science into the treatment of a disorder in which we all have a great interest. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
On March 15th, 2010, the SCOLISCORE™ AIS Prognostic Test became the spine industry’s first prognostic test designed to utilize validated genetic markers to assess the likelihood of AIS curve progression. With the launch of this promising new technology, the responsibility to provide peer-reviewed, evidence based publications to the scientific community, which support the clinical validity and high predictive accuracy of the SCOLISCORE Test, is of paramount importance to both DePuy Spine and Axial Biotech. With this in mind, it is with great excitement that we inform you that the journal, SPINE, has just published on-line, a landmark paper on Prognostic Genetic Testing for AIS, featuring the SCOLISCORE Test. http://journals.lww.com/spinejournal...urrenttoc.aspx landmark paper represents years of research by world-renowned geneticists and spine surgeons, in classifying the genetic markers that predict which minor AIS curves are not likely to progress to a severe curve. Clinical use since launch of the SCOLISCORE Test has demonstrated that the knowledge of a patient’s genetic predisposition to curve progression, when combined with existing radiographic and clinical information, has empowered physicians and families to make more informed, personalized, clinically actionable patient care decisions. This This is an exciting time in the treatment of complex spinal deformity. While the introduction of the SCOLISCORE Test and the recent SPINE publication are important steps toward the advancement of care of spine patients, our organizations remain committed to working with thought-leading physicians to continue to develop transformational technologies which improve the standard of care for patients with debilitating conditions of the spine. We encourage you to take a moment to download this pivotal paper to learn more about the clinical validation trials behind the highly predictive and accurate SCOLISCORE Test. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
What role do environmental factors play in scoliosis?
Scoliosis is a complex condition that involves both genetic and environmental factors. The more a patient is genetically pre-disposed to developing the condition the less environmental factors they will need to incur to before developing scoliosis. Of course the opposite is true as well. A patient with a low pre-disposal for genetic factors for scoliosis, but high environmental factors galore may also have the same overall risk of developing the condition and the genetically high risk patient.
We can't change our genes (yet), so we are left with only having the ability to reduce/eliminate the environmental factors that (when combined with genetic factors) cause Adolescent Idiopathic Scoliosis (AIS).
So how much affect do environmental factors have on scoliosis? Well, let's look at it from this perspective.
Approximately 4% of all scoliosis cases chose to have the spinal fusion surgical procedure (and that doesn't include the patients who refuse the procedure) and the Scoliscore genetic test predicts that only 1% of patients should have the genetic pre-disposition to develop a curvature that would reach surgical level.
The conclusion: At least 3% of the 4% of AIS cases going to spinal fusion surgery are due to environmental factors driving the condition, not just genetic pre-disposition.
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The evidence and studies are proving time and time again that back bracing for scoliosis has no effect on the curvature or natural progression of the condition. This study even compared the results of bracing vs. the genetic testing predicted outcomes. The results clearly show that bracing for scoliosis provides no benefit to the patient. Does bracing alter the natural history of Adolescent Idiopathic Scoliosis? J Ogilvie , L Nelson, R Chettier and K Ward Department of Orthopaedic Surgery, University of Utah, Salt Lake City, UT, USA author email corresponding author email from 6th International Conference on Conservative Management of Spinal Deformities Scoliosis 2009, 4(Suppl 2):O59doi:10.1186/1748-7161-4-S2-O59 The electronic version of this abstract is the complete one and can be found online at: http://www.scoliosisjournal.com/content/4/S2/O59 Published: 14 December 2009 © 2009 Ogilvie et al; licensee BioMed Central Ltd. Background Orthotic treatment of children with AIS is a generally accepted treatment option. Failure of bracing to halt curve progression has been reported in 20% or more of patients, and it is known that some curves in children with AIS will not progress even if untreated. Success and failure rates of brace treatment vary considerably. Purpose We reviewed the response to brace treatment in patients who were also analyzed with a DNA-based adolescent idiopathic scoliosis progression test (AIS-PT) and compared this with the natural history of adolescent idiopathic scoliosis without treatment. Our purpose was to document the influence of orthotic care on the outcome at skeletal maturity. Methods Medical records and x-rays were reviewed, and DNA was collected with a saliva sample in two cohorts of Caucasian female AIS patients. A risk of progression score was calculated using 53 genetic markers with utility for calculating the risk of AIS curve progression from < 25° to > 40° before skeletal maturity or > 50° at maturity (1-200). Group A (2442 females) had no brace treatment and their outcome at maturity or surgery was known. Group B (308 females) were brace compliant for more than one year and their curve severity at maturity or surgery was known. Results There was little statistical difference in the curves representing risk of progression versus curve severity when the two groups were compared.
Conclusion In this retrospective study of US Caucasian females, there was no statistically significant difference in the natural history of adolescent idiopathic scoliosis when comparing bracing treatment and no bracing treatment. At best, there was only a modest brace effect. Prospective trials with genotype homogeneity are needed to validate current assumptions about the efficacy of orthotic types and treatment regimens when bracing adolescent idiopathic scoliosis. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
Does bracing for scoliosis work? In a word, No. Here is yet another study that demostrates that bracing does not change the natural course of scoliosis. This article even compared the bracing outcomes vs what the genetic testing (scoliscore) predicts. The outcomes are exactly the same, which means back bracing for scoliosis had no effect.
Here is the article. Does bracing alter the natural history of Adolescent Idiopathic Scoliosis? J Ogilvie , L Nelson, R Chettier and K Ward Department of Orthopaedic Surgery, University of Utah, Salt Lake City, UT, USA author email corresponding author email from 6th International Conference on Conservative Management of Spinal Deformities Scoliosis 2009, 4(Suppl 2):O59doi:10.1186/1748-7161-4-S2-O59 The electronic version of this abstract is the complete one and can be found online at: http://www.scoliosisjournal.com/content/4/S2/O59 Published: 14 December 2009 © 2009 Ogilvie et al; licensee BioMed Central Ltd. Background Orthotic treatment of children with AIS is a generally accepted treatment option. Failure of bracing to halt curve progression has been reported in 20% or more of patients, and it is known that some curves in children with AIS will not progress even if untreated. Success and failure rates of brace treatment vary considerably. Purpose We reviewed the response to brace treatment in patients who were also analyzed with a DNA-based adolescent idiopathic scoliosis progression test (AIS-PT) and compared this with the natural history of adolescent idiopathic scoliosis without treatment. Our purpose was to document the influence of orthotic care on the outcome at skeletal maturity. Methods Medical records and x-rays were reviewed, and DNA was collected with a saliva sample in two cohorts of Caucasian female AIS patients. A risk of progression score was calculated using 53 genetic markers with utility for calculating the risk of AIS curve progression from < 25° to > 40° before skeletal maturity or > 50° at maturity (1-200). Group A (2442 females) had no brace treatment and their outcome at maturity or surgery was known. Group B (308 females) were brace compliant for more than one year and their curve severity at maturity or surgery was known. Results There was little statistical difference in the curves representing risk of progression versus curve severity when the two groups were compared. Conclusion In this retrospective study of US Caucasian females, there was no statistically significant difference in the natural history of adolescent idiopathic scoliosis when comparing bracing treatment and no bracing treatment. At best, there was only a modest brace effect. Prospective trials with genotype homogeneity are needed to validate current assumptions about the efficacy of orthotic types and treatment regimens when bracing adolescent idiopathic scoliosis. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
Is the future of scoliosis treatment here? Could a cure for scoliosis be just around the corner? Possibly. Just look at this statement by George H. Thompson (past president of the SRS) Future of Scoliosis Treatment George H. Thompson, MD Past President, Scoliosis Research Society The treatment of idiopathic scoliosis, particularly conservative treatment, has been controversial. It has been difficult to determine which patients were going to progress, and who would benefit from conservative treatment (physical therapy, bracing, etc.) or require surgery.
The technology already exists to create a brace-free, fusion-free scoliosis world a reality. We just need to connect the dots and link the existing technologies into a treatment program that is directed by the genetic testing (scoliscore), rather than Cobb angle. It is just a matter of having the right conversations, with the right people, at the right time. Stay tuned. |
