Опубликованные клинические данные
Eur Spine J (2013) 22:1030–1036
Пациенты, подвергаемые высокому риску при дискэктомии: профилактика рецидива грыжи у пациентов с большими дефектами фиброзного кольца с использованием устройства для закрытия дефекта фиброзного кольца.
GJ Bouma, M Barth, D Ledic, M Vilendecic
Абстракт »
Abstract:
Purpose With lumbar discectomy for disc herniation, surgeons must choose between limited nucleus removal associated with higher reherniation risk or more aggressive nucleus removal associated with increased back pain and disc degeneration. This trade-off is particularly challenging in patients with large anular defects, which carry the highest risk of reherniation. We examined the effect of an anular closure device on reherniation and clinical outcomes.
Methods Seventy-five primary discectomy patients had a limited discectomy followed by implantation of an anular closure device and were followed-up to 2 years. Anular defect size and volume of removed nucleus was recorded at surgery. Reherniations were reported, pain and function were monitored throughout, and imaging was performed at annual visits.
Results The overall symptomatic reherniation rate was 1.4 %, and the asymptomatic reherniation rate was 1.5 % at 12 months and 5.1 % at 24 months. Both rates compare favorably with literature reports which include symptomatic rates ranging between 2 and 18 % (up to 27 % for patients with large anular defects) and an asymptomatic rate of 13 %.
Conclusions The low reherniation rate in patients at high risk of reherniation based on anular defect size, despite discectomy being only limited, suggests that an anular closure device may reduce reherniation risk. Clinical outcomes for pain and function at 1 and 2 years post-operatively compared favorably with literature reports. Further study in a randomized controlled trial is required to confirm these results.
Korean J Spine 9(4):340-347, 2012
Первичная ограниченная дискэктомия на поясничном отделе позвоночника с использованием устройства закрытия дефекта фиброзного кольца: клинические и радиографические результаты, полученные через год после дискэктомии в проспективном многоцентровом исследовании.
M Lequin, M Barth, C Thomé, GJ Bouma
Абстракт »
Abstract:
Purpose Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. Annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor.
Methods We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid after a limited discectomy. Annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up.
Results At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed.
Conclusions The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing face degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid is currently underway, and will provide a higher level of evidence.
J Neurol Surg A Cent Eur Neurosurg. 13 мая 2013 года 13, DOI: 10.1055/s-0033-134116
Экономия, связанная с профилактикой рецидивов грыж в межпозвоночном диске поясничного отдела позвоночника: многоцентровое проспективное когортное исследование)
SL Parker, G Grahovac, D Vukas, D Ledic, M Vilendecic, MJ McGirt
Абстракт »
Abstract:
Purpose Estimate cost savings due to reduction in reoperation for reherniation: Two-year (final) results of Phase 2 Barricaid patients vs. inclusion-matched historical controls from same sites
Results Annular closure and control cohorts were matched at baseline. By two years follow-up, symptomatic recurrent same-level disc herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular closure cohort. For patients experiencing recurrent disc herniation, mean estimated direct and indirect cost of management of recurrent disc herniation was $34,242 and $3,778, respectively. Use of an annular closure device potentially results in a cost savings of $222,573 per 100 primary discectomy procedures performed (or $2,226 per discectomy), based solely on the reduction of re-operated reherniations when modeled on US Medicare costs.
Conclusions Recurrent disc herniation did not occur in any patients after annular closure. The reduction in the incidence of re-herniation was associated with potentially significant cost savings. Development of novel techniques to prevent recurrent lumbar disc herniation is warranted to decrease the associated morbidity and healthcare costs associated with this complication.
BSD Journal of Spinal Disorders and Techniques Publish Ahead of Print; DOI:10.1097/BSD.0b013e3182956ec5
Влияние нового устройства для закрытия дефекта фиброзного кольца (Barricaid) на уровень рецидивов грыжи диска и снижение высоты диска после первичной дискэктомии в поясничном отделе позвоночника: результаты через два года после вмешательства, полученные в ходе многоцентрового проспективного когортного исследования.
Parker et al
Абстракт »
Abstract:
Purpose Two-year (final) results of Phase 2 Barricaid patients vs. inclusion-matched historical controls from same sites.
Results Annular repair and control cohorts were well matched at baseline. By two-years follow-up, symptomatic recurrent same-level disc herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular repair cohort (p=0.27). A trend of greater preservation of disc height was observed in the annular repair versus control cohort three months (7.9 vs. 7.27mm, p=0.08), six months (7.81 vs. 7.18mm, p=0.09), and twelve months after surgery (7.63 vs. 6.9mm, p=0.06). The annular closure cohort reported less leg pain (VAS-LP: 5 vs. 16, p<0.01), back pain (VAS-BP: 13 vs. 22, p<0.05), and disability (ODI: 16 vs. 22, p<0.05) one year after surgery.
Conclusions Implantation of a novel annular repair device was performed without any device-related acute adverse events and was associated with greater maintenance of disc height and improved one-year leg pain, back pain, and low-back disability. Recurrent disc herniation did not occur in any patients after annular repair. Closure of the annular defect after lumbar discectomy may help preserve physiologic disc function and prevent long-term disc height loss and associated back and leg pain.
Clin Neurol Neurosurg. 2013, DOI: 10.1016/j.clineuro.2013.01.007
Защита фасеточных суставов после дискэктомии на поясничном отделе позвоночника: Устройство для закрытия дефекта фиброзного кольца Barricaid снижает риск дегенерации фасеточных суставов.
M Trummer, S Eustacchio, M Barth, PD Klassen, S Stein
Абстракт »
Abstract:
Purpose Effect of Barricaid on facet degeneration one year following discectomy
Object Facet joint degeneration after discectomy may be the result of excessive nuclear removal, disc space narrowing, and annular injury. This study investigated whether implantation with the Barricaid Annular Closure Device (ACD) during discectomy reduced the rate of facet degeneration.
Methods Inclusion criteria were primary lumbar disc herniation failing conservative treatment, Visual Analog Scale (VAS) Leg ≥ 40/100, Oswestry Disability Index (ODI) ≥ 40/100 and defects that were ≤ 60 mm2 (Barricaid arm only), and patient age 18-75. CT interpretations were collected preoperatively and 12 months post-discectomy. Paired preoperative and 12 month follow-up CT Scans were available for 94 Discectomy-only patients and 63 Barricaid patients. Grading was performed by a single radiologist, per the four-point scale of Pathria et al (1987).
Select results Defining facet degeneration as an increase of at least one grade on the four-point scale, at 12 months the discectomy-only group had a significantly higher rate of facet degeneration than the Barricaid group (43% vs. 24%; p=0.015, Fisher’s Exact).
Conclusions ACDs may be able to maintain disc space height and reduce facet degeneration by minimizing the amount of nuclear material that is removed during disectomy. Our findings support this theory and suggest that implantation with the Barricaid during discectomy has significant benefits in disc space maintenance and facet degeneration risk. The fact that none of the clinical outcome scores demonstrated statistically significant benefits from Barricaid implantation emphasizes the need for longer follow-up studies in the future.
Spine (2013) 38(10) pp E587–E593
Возможно ли изучение профилактики рецидива межпозвоночной грыжи? Создание модели образования межпозвоночной грыжи и эксперименты с устройством для закрытия дефекта фиброзного кольца.
HJ Wilke, L Widmann, F Heuer, N Graf, S Rath
Абстракт »
Abstract:
Purpose Cadaver testing: Barricaid in discs that herniated without the Barricaid
Objective To establish a reliable in vitro herniation model with human cadaver spines and to apply it with an annulus reconstruction implant already in clinical use.
Background From a biomechanical point of view it would be desirable to close an annulus defect after a herniation to preserve as much nucleus material as possible. Today, there are only a few such annular closure approaches available to prevent a reherniation of an intervertebral disc. It would be desirable to have test procedures available, which show the efficacy and reliability of new implants.
Methods Three groups of un-embalmed human lumbar segments were tested under cyclic loading until herniation occurred. In a first part of this study a standardized defect was closed with an implant and compared to a control group left untreated. Unfortunately, specimen variability resulted in unreliable herniation potential. Therefore, in the second part intradiscal pressure measurements had to prove a high extrusion risk before specimens were selected. This time, in each specimen extruded material was pushed back into the disc and the annulus defect was treated with the Barricaid annular closure device (Intrinsic Therapeutics Inc., Woburn, MA USA). Disc height and 3D-flexibility of the intact, defect and implanted specimens were measured in a spine tester. Afterwards re-herniation was provoked with 100.000 cycles of loading.
Results Using this worst-case model herniation caused a significant reduction of disc height, which was almost restored with the implant. In no case was a re-herniation or implant migration visible after 100.000 load cycles following Barricaid implantation.
Conclusions We established a human herniation model that reliably predicted and generated nucleus extrusion during cyclic loading. The Barricaid seems to prevent the nucleus from re-herniating. The reliability of this method suggests the opportunity to critically investigate other annulus sealing methods and nucleus replacement techniques in combination with annulus sealing methods.
ПОДБОРКА ОПУБЛИКОВАННЫХ ДАННЫХ ПО BARRICAID®
Пожалуйста нажмите здесь, чтобы скачать последний список опубликованных клинических данных по Barricaid®.
ВОЗМОЖНЫЕ ИСХОДЫ ЧЕРЕЗ ОДИН И ДВА ГОДА ПОСЛЕ ОПЕРАЦИИ ПО ДАННЫМ ОПУБЛИКОВАННЫХ ПРОСПЕКТИВНЫХ ИССЛЕДОВАНИЙ
РЕЗУЛЬТАТЫ
При минимальном периоде наблюдений в 12 месяцев сообщается, что пациенты с Barricaid® демонстрируют статистически значимое превышение благоприятных исходов для двух критериев оценки дискэктомии – риска рецидивов и сохранения высоты диска.
СОХРАНЕНИЕ ВЫСОТЫ ДИСКА
*По сравнению с высотой диска до операции
ДАННЫЕ О БОЛЕЕ БЛАГОПРИЯТНЫХ ИСХОДАХ ДЛЯ ПАЦИЕНТОВ
Хотя исследования не ставили целью продемонстрировать существенные улучшения в клинических исходах непосредственно для пациентов, в ходе их проведения проявились выраженные тенденции и существенные улучшения в исходах лечения с применением Barricaid®.
ВИЗУАЛЬНАЯ АНАЛОГОВАЯ ШКАЛА БОЛИ В НИЖНИХ ОТДЕЛАХ СПИНЫ
ВИЗУАЛЬНАЯ АНАЛОГОВАЯ ШКАЛА ИПСИЛАТЕРАЛЬНОЙ БОЛИ В НОГЕ
ИНДЕКС ОБЩЕЙ ДЕЕСПОСОБНОСТИ ОСВЕСТРИ
Все p-значения, рассчитанные по критерию Вилкиксона-Ранка (непараметрическому)
Совокупные показатели успешного лечения через 1 год
На основании совокупных данных, полученных во всех исследованиях, при последующих наблюдениях через год после вмешательства, статистически доказано преимущество Barricaid по такому параметру как минимально приемлемое клинически значимое улучшение.
p-значения на основе одностороннего точного критерия Фишера
Продолжающиеся клинические испытания
В Европе
Многоцентровое международное рандомизированное проспективное контролируемое исследование превосходства метода с применением Barricaid® по сравнению с обычной ограниченной дискэктомией.
В декабре 2010 года Intrinsic Therapeutics инициировала одно из крупнейших из когда-либо проводимых исследований на позвоночнике с целью демонстрации явного преимущества лечения с использованием Barricaid® у пациентов с ограниченной дискэктомией.
Центры, принимающие участие в исследовании
В испытании принимают участие от 15 до 20 клинических центров из Германии, Нидерландов, Бельгии, Австрии и других стран.
Популяция пациентов
Испытание является исследованием с интраоперационной рандомизацией в соотношении 1:1, проводимым с целью сравнения ограниченной дискэктомии с применением Barricaid® и обычной ограниченной дискэктомии. В исследовании используют план статистического контроля Байеса, который позволяет включить в испытание 400-800 пациентов.
В исследование включили пациентов, среди которых имеется заранее установленная доля пациентов, имеющих максимальные шансы на получение пользы от сохранения оставшейся части диска за счет Barricaid® и минимально необходимую высоту диска, а также минимальный размер дефекта и отсутствие в анамнезе повторных операций и рецидивов грыж.
Конечные точки
Вывод об успехе лечения у пациентов с Barricaid® делают на основе статистического превосходства по двум первичным критериям оценки исследования:
-
Выживаемость без рецидива межпозвоночной грыжи
-
Комбинированный критерий оценки, включающий снижение болей в ноге, индекс общей дееспособности Освестри, сохранение высоты диска и отсутствие повторной операции на заданном уровне.
Последующее наблюдение
Данное исследование будет являться наиболее полным из проведенных до настоящего времени исследований на пациентах с дискэктомией с целью сбора всех значимых клинических и радиографических данных. Полученный набор данных будет использован не только для демонстрации превосходства Barricaid®, но также и для анализа влияния дооперационных данных и интраоперационных методик на клинические исходы дискэктомии.
Обсуждение
Дополнительную информацию о данном испытании можно найти на сайте www.Barricaid-Study.eu
Intrinsic Therapeutics также взяла на себя обязательство оказывать содействие заинтересованным центрам в проведении исследований и независимых испытаний рабочих характеристик устройства на условии возмещения затрат. Заинтересованные стороны могут связаться с нами, используя имеющуюся на сайте форму. Наш сотрудник свяжется с вами, чтобы обсудить условия вашего участия.