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Displaying items by tag: vertebral body stapling
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Unfortunately, the lowest common denominator that all non-surgical scoliosis treatments have in common is the hope of preventing the "need" for scoliosis surgery......standing at approximately 38,000 per year in the US right now. I say that it is "unfortunate", because this seems like it should be a rather low bar to hurdle, but to date no one has been able to effectively demonstrate the ability to do this on a large scale. The advent of genetic testing (Scoliscore) will provide the necessary genetic predisposition data to determine if a given non-surgical treatment has actually altered the natural course of the condition, so hope is on the horizon, but to simply boil down all treatment effort to avoiding surgery is abandoning a much loftier and noble goal of finding a cure. I would rather fail attempting to achieve high expectations, than succeed achieving low standards. The current review of scoliosis brace data clearly demostrates that brace treatment does NOT reduce the rate of scoliosis surgery (Weinstein, 2007 and Oglivie, 2009); and rehab based programs like Schroth, CLEAR Institute, FITS, SEAS, Yoga, Pilates, ect haven't produced any large scale data to determine effectiveness in reducing surgical rates at this time, so we're in a bit of a tough spot here. It has always been stated that one of the greatest challenges the scoliosis practioner has had was determining which cases would progress and how far, but in reality bracing's known and proven inability to alter the natural course of the condition made that a moot point anyway, and essentially there is nothing standing between the adolescent idiopathic scoliosis (AIS) patient and surgical intervention except genetic predisposition and luck. This is simply unacceptable. The gap between prognostic testing for AIS and the ability to alter the natural course that prognostic testing can help predict is wide and widening further by the day. We have entered a realm in which we can tell a patient they are essentially a ticking time bomb for severe scoliosis, but there is no way to de-fuse it, so sit back, watch it get worse and we'll perform a highly invasive surgical procedure that very often results in long-term chronic pain and disability once the curve gets bad enough. Again, this is simply unacceptable. So what can be done to lower the rate of spinal fusion rates for scoliosis in the future? 1. Earlier detection of small curves. This allows for genetic testing to determine genetic predisposition and the opportunity for early stage scoliosis intervention for the patients whom are at elevated risk for severe curve progression. 2. Early Stage Scoliosis Intervention. A neuro-muscular re-education based rehab program that targets the involuntary postural control centers of the brain stem that will "re-train" the brain to hold the spine in a straighter position automatically....when the spinal curvature is still relatively small and flexible for maximum benefit to the patient. 3. Vertebral Body Stapling (VBS). This is a relatively new, minimally invasive non-fusion surgical procedure which provides a "guided bone growth" type mechanism. It is mostly indicated for juvenile scoliosis cases, but could be used in certain "high genetic risk predisposition" AIS cases if the curve is discovered at an early enough age and the patient fails to respond to the early stage scoliosis intervention program. 4. Improved spinal rehab techniques for patients with larger spinal curvatures. As effective any any screening program could be and as well as any early stage scoliosis intervention program is, there will always be some patients whom "fall through the cracks" and need an effective rehab based program that is specifically designed and targets the unique biomechanical needs of patients with large spinal curves. To date, it appears that only CLEAR and Schroth are making in roads into this area. 5. Increased patient education in the risk/benefit and long-term consequences to chosing surgical intervention for scoliosis. Scoliosis surgery is not medically necessary...even in very severe cases....and is almost entirely based on improving the cosmetic deformity of the condition. However, trading deformity for dysfunction comes with a very steep price......chronic pain, hardware failure, rapid degeneration around the non-fused areas, ect. In short, many scoliosis patients would be far better off doing nothing than choosing spinal fusion surgery. They should be more aware and better educated on the fact that they indeed do have a "choice". This is certainly not an exhaustive list, nor is it beyond debate, so please feel free to dispute, comment, or add to this discussion as you see fit. 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. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
STUDY DESIGN: Retrospective review.
OBJECTIVES: To report the feasibility, safety, and utility of vertebral body stapling without fusion as an alternative treatment for adolescent idiopathic scoliosis.
SUMMARY OF BACKGROUND DATA: The success rate of brace treatment of adolescent idiopathic scoliosis ranges from 50% to 82%. However, poor self-image and brace compliance are issues for the patient. An alternative method of treatment such as a motion-preserving vertebral body stapling to provide curve stability would be desirable.
METHODS: We retrospectively reviewed 21 patients (27 curves) with adolescent idiopathic scoliosis treated with vertebral body stapling. Patients were immature as defined by Risser sign <or=2.
RESULTS: The concept of vertebral body stapling of the convex side of a patient with adolescent idiopathic scoliosis is feasible. The procedure was safe, with no major complications and three minor complications. One patient had an intraoperative segmental vein bleed resulting in an increased estimated blood loss of 1500 cc as compared to the average estimated blood loss of 247 cc for all patients. One patient had a chylothorax and one pancreatitis. No patient has had a staple dislodge or move during the follow-up period (mean 11 months, range 3-36 months), and no adverse effects specifically from the staples have been identified. Utility (defined as curve stability) was evaluated in 10 patients with stapling with greater than 1-year follow-up (mean 22.6 months) and preoperative curve <50 degrees. Progression of >or=6 degrees or beyond 50 degrees was considered a failure of treatment. Of these 10 patients, 6 (60%) remained stable or improved and 4 (40%) progressed. One of 10 (10%) in the stapling group had progressed beyond 50 degrees and went on to fusion. Six patients required stapling of a second curve, three as part of the primary surgery, and three as a second stage, because a second untreated curve progressed. The results need to be considered with caution, as the follow-up is still short.
CONCLUSIONS: The data demonstrate that vertebral body stapling for the treatment of scoliosis in the adolescent was feasible and safe in this group of 21 patients. In the short-term, stapling appears to have utility in stabilizing curves of progressive adolescent idiopathic scoliosis.
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Thirty-nine consecutive patients have had vertebral body stapling of 52 curves (26 patients with one curve stapled and 13 with two). For the group with patients who were 8 years or older with less than 50 degrees preoperative curve and a minimum 1-year followup, coronal curve stability was 87% when defined by progression less than or equal to 10 degrees . Fusion was necessary in two patients. No curves less than 30 degrees at the time of stapling progressed greater than or equal to 10 degrees . Major complications occurred in one patient (2.6%, diaphragmatic hernia) and minor complications occurred in five patients (13%). Further followup of the patient cohort and further research into efficacy and indications are warranted.
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STUDY DESIGN: Absolute and relative growth modulation of apical spinal segments were measured during creation and correction of an experimental scoliosis in a goat model.
OBJECTIVE: To differentiate relative and absolute changes in growth on the concavity and convexity of an experimental scoliosis treated with anterior vertebral stapling.
SUMMARY OF BACKGROUND DATA: The creation and correction of vertebral wedge deformities have been previously described in a rat tail model using external fixation as well as in a goat model using anterior vertebral body stapling.
METHODS: Progressive, structural, scoliotic curves convex to the right in the thoracic spine were created in 14 Spanish Cross-X female goats using a posterior asymmetric tether. After 7-13 weeks, all tethers were removed, and goats were randomized into stapled (n = 8) and untreated (n = 6) groups. Stapled goats underwent anterior vertebral stapling with 4 shape memory alloy staples (Medtronic Sofamor Danek, Memphis, TN) along the convexity of the maximal curvature. All goats were observed for an additional 7-13 weeks. There were 12 additional goats matched for age, sex, and weight used as growth controls throughout the study. Serial radiographs were used to document progression or correction of the maximal scoliotic deformity, and changes in relative and absolute growth at the apical spinal segment T9-10 (2 adjacent vertebrae and the intervening disc).
RESULTS: All tethered goats had progressive, structural, scoliotic curves of significant magnitude during the tethering period (average 61.4 degrees, range 49 degrees to 73 degrees) (P = 0.001). There was 1 goat from each group eliminated from the study because its apical spinal segment did not match the T9-10 level used to establish normal growth in controls. During the treatment period, stapled goats had a correction of -6.9 degrees (P = 0.03), whereas untreated goats had little change (-1.4 degrees). Apical spinal segment wedging progressed in all tethered goats, from 11.1 degrees to 22.4 degrees, during the tethering period (P = 0.001). During the treatment period, wedging corrected -2.2 degrees (range 22.5 degrees to 20.3 degrees) in the stapled goats but progressed +3.5 degrees (range 22.3 degrees to 25.8 degrees) in the untreated goats (P < 0.05). Apical spinal segment growth in all tethered goats was decreased on the concavity by 78% and increased on the convexity by 33% when compared to growth controls (P < 0.001). During the treatment period, growth on the concavity of the apical spinal segment of the stapled goats was decreased by 10% but increased in the untreated goats by 37% when compared to growth controls. On the convexity, apical spinal segment growth at T9-10 was decreased in the stapled goats by 18% and increased in the untreated goats by 29% when compared to growth controls (P < 0.04). CONCLUSIONS: Data in this study show the ability to modulate relative and absolute growth, according to the Hueter-Volkmann law, at the apical spinal segment of a progressive experimental scoliosis. However, anterior vertebral stapling, although able to control progressive wedging and scoliosis at the apical spinal segment, was not able to reverse fully the Hueter-Volkmann effect.
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The recent investigations of convex anterior vertebral body stapling have offered promising early results with use of improved implants and techniques. The use of a shape memory alloy staple tailored to the size of the vertebral body, the application of several staples per level, the instrumentation of the Cobb levels of all curves, and the employment of minimally invasive thoracoscopic approaches all offer substantial improvements over previous fusionless techniques. Patient selection may also play a role in the current success of these fusionless treatments, with perhaps the ideal candidates for this intervention possessing smaller and more flexible curves. Long-term results of the effects on the instrumented motion segments and adjacent spine are not yet available.
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Progressive scoliosis in the growing child poses a unique challenge. The surgeon aims to attain maximal curve correction while maintaining spinal and thoracic growth. Nonoperative treatments include bracing and serial casting (both with questionable results). The classic surgical treatment has been spine fusion with less than optimal results. This has resulted in the development of fusionless interventions for children with scoliosis. These include growing rods, intervertebral body stapling, and the vertical expandable prosthetic titanium rib. Each of these offers unique advantages and disadvantages.
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Endoscopic vertebral body stapling is an innovative technique intended to treat adolescent idiopathic scoliosis, but the optimal instrumentation design is not yet established. The objective was to simulate the immediate correction obtained from two stapling configurations. A parametric finite element model of a typical right thoracic scoliotic spine (Cobb 21 degrees ) was developed using geometrical and mechanical data from the literature. Staple insertion and closing were modeled. The intra-operative lateral decubitus and standing positions were taken into account. Two implant configurations, varying the number of staples per vertebra, were simulated. The major correction (9 degrees ) came by simulating the intra-operative posture. The immediate Cobb angle correction due to the staples alone was less then 1 degrees for both configurations. However, the staples helped maintain the correction obtained by the intra-operative posture when the post-operative standing position was simulated. Next steps are to validate the model using surgical cases, implement growth modulation modeling, improve lateral decubitus modeling, and analyze different vertebral stapling strategies for different scoliotic curves.
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Anterior vertebral body stapling is a new minimally invasive technique to correct scoliotic deformities without fusion. In the literature only preliminary reports with short follow-up periods are available. A total of six patients with a minimum follow-up of 2 years were available for examination.
Of the six patients, four demonstrated progression of scoliosis in spite of vertebral body stapling. All had curves of more than 35 degrees at the time of surgery, while two patients with less extensive curves below 35 degrees did not show signs of progression. Major complications were not observed. Vertebral body stapling for curves more than 35 degrees does not seem to be indicated and careful patient selection for stapling may be indicated for curves less than 35 degrees. A more general use of this technique is not recommended at this time.
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*** Note, VBS is generally is NOT indicated for adolescent idiopathic scoliosis due to lack of suffient spinal growth potential past the age of 12 years old.
STUDY DESIGN: Retrospective review.
OBJECTIVE: To report the results of vertebral body stapling (VBS) with minimum 2-year follow-up in patients with idiopathic scoliosis.
SUMMARY OF BACKGROUND DATA: While bracing for idiopathic scoliosis is moderately successful, its efficacy has been called into question, and it carries associated psychosocial ramifications. VBS has been shown to be a safe, feasible alternative to bracing for idiopathic scoliosis.
METHODS: We retrospectively reviewed 28 of 29 patients (96%) with idiopathic scoliosis treated with VBS followed for a minimum of 2 years. Inclusion criteria: Risser sign of 0 or 1 and coronal curve measuring between 20 degrees and 45 degrees .
RESULTS: There were 26 thoracic and 15 lumbar curves. Average follow-up was 3.2 years. The procedure was considered a success if curves corrected to within 10 degrees of preoperative measurement or decreased >10 degrees . Thoracic curves measuring <35 degrees had a success rate of 77.7%. Curves which reached < or =20 degrees on first erect radiograph had a success rate of 85.7%. Flexible curves >50% correction on bend film had a success rate of 71.4%. Of the 26 curves, 4 (15%) showed correction >10 degrees. Kyphosis improved in 7 patients with preoperative hypokyphosis (<10 degrees of kyphosis T5-T12). Of the patients, 83.5% had remaining normal thoracic kyphosis of 10 degrees to 40 degrees. Lumbar curves demonstrated a success rate of 86.7%. Four of the 15 lumbar curves (27%) showed correction >10 degrees. Major complications include rupture of a unrecognized congenital diaphragmatic hernia and curve overcorrection in 1 patient. Two minor complications included superior mesenteric artery syndrome and atelectasis due to a mucous plug. There were no instances of staple dislodgement or neurovascular injury.
CONCLUSION: Analysis of patients with idiopathic scoliosis (IS) with high-risk progression treated with vertebral body stapling (VBS) and minimum 2-year follow-up shows a success rate of 87% in all lumbar curves and in 79% of thoracic curves <35 degrees. Thoracic curves >35 degrees were not successful and require alternative treatments.
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