Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

Официальное название

Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial

Обзор

Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms. The study's precise objectives are to: 1. evaluate the clinical outcome (Oswestry Disability Index) 2. evaluate the radiography result (restoration and maintenance of spinal alignment) 3. determine the prevalence of complications at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.

Подробное описание

The research is a single-center, nationwide, randomized controlled trial. Over a two-year period, 52 patients with a thoracolumbar burst fracture will enroll in the study. They will be assigned randomly (1:1) to either non-surgical treatment with a brace or surgery with anterior-posterior fixation. A prospective data collection will be asked of subjects who decline randomization (observational arm). The subjects will be evaluated clinically, radiologically, and based on patient-reported outcomes over the course of two years. Both patient files and questionnaires will be used to collect data.

Вмешательства

• Процедура Surgical stabilization
  Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage

Первичные конечные точки

• The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation [Срок оценки: 2 years after fracture]

Вторичные конечные точки (12)

• Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle [Срок оценки: Pre-Treatment to 2 years after the fracture]
• Radiological outcome: Spinal fusion and fracture consolidation [Срок оценки: 26 weeks after fracture]
• Radiological outcome: Segment mobility [Срок оценки: 52 weeks after fracture]
• Radiological outcome: Degeneration of the intervertebral disc over time [Срок оценки: Pre-Treatment, 52 weeks after the fracture]
• Radiological outcome: Progression of spinal canal stenosis [Срок оценки: From the time of fracture, 26 weeks and 52 weeks]
• Non-surgical treatment failure rate [Срок оценки: From the time of fracture to 2 years after the fracture]
• Complication rate and severity and additional surgeries [Срок оценки: 6, 12, 26, 52, and 104 weeks]
• Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST) [Срок оценки: From the time of fracture to 2 years after the fracture]
• Changes in patient-related outcome measurements: EQ5D-3L [Срок оценки: Pre-Treatment to 2 years after the fracture]
• Changes in patient-related outcome measurements: Pain visual analogue scale (VAS) [Срок оценки: Pre-Treatment to 2 years after the fracture]
• Indirect costs [Срок оценки: 6, 12, 26, 52, and 104 weeks]
• Treatment data: Length of hospitalization (days) [Срок оценки: Pre-Treatment to discharge from hospital]

Критерии участия

Критерии включения

• Age 18 - 70 years at inclusion
• Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
• Informed consent for study participation

Критерии исключения

• Injury of the posterior tension band/posterior column of the thoracolumbar spine
• Any neurological deficit (American Spinal Injury Association Impairment Scale \[AISA\] Grade A-D)
• Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
• Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
• Multiple trauma or Injury Severity Score (ISS) > 16 or additional injuries according to the investigator may, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study (impairment of early ambulation)
• Any known previous spinal surgery in the thoracolumbar spine, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
• Any severe, progressive, or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study
• Known history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment in the opinion of the investigator
• Pregnancy or women planning to conceive within the study period. All women included in this study must have a negative blood pregnancy test (human chorionic gonadotrophin (hCG) blood level at visit 1. If pregnancy occurs during the study period, the patients drop out of the study
• Inability to follow the procedures of the study, e.g., due to inability to understand German, French or English, which, according to the investigator, may jeopardize the patient in case of participation in the study or prevents the patient from participating in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• Inselspital — Bern
• Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen — Sankt Gallen

Публикации

• Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5. PMID 22057820
• Vaccaro AR, Oner C, Kepler CK, Dvorak M, Schnake K, Bellabarba C, Reinhold M, Aarabi B, Kandziora F, Chapman J, Shanmuganathan R, Fehlings M, Vialle L; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013 Nov 1;38(23):2028-37. doi: 10.1097/BRS.0b013e31 PMID 23970107
• Oner FC, Wood KB, Smith JS, Shaffrey CI. Therapeutic decision making in thoracolumbar spine trauma. Spine (Phila Pa 1976). 2010 Oct 1;35(21 Suppl):S235-44. doi: 10.1097/BRS.0b013e3181f32734. PMID 20881467
• Spiegl UJ, Fischer K, Schmidt J, Schnoor J, Delank S, Josten C, Schulte T, Heyde CE. The Conservative Treatment of Traumatic Thoracolumbar Vertebral Fractures. Dtsch Arztebl Int. 2018 Oct 19;115(42):697-704. doi: 10.3238/arztebl.2018.0697. PMID 30479250

Идентификаторы

NCT: NCT05769114 · 2022-00662

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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