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| Name | Class |
|---|---|
| Cantonal Hospital of St. Gallen | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Active Comparator | The surgeon will perform a minimally invasive (percutaneous) posterior stabilization of the injured spinal segments. Transpedicular screws will be inserted into the vertebral body superior and inferior to the fractured vertebra under fluoroscopic control. In a second stage procedure a lumbo- or thoracotomy (depending on the fracture level below or above the diaphragm) is performed to remove the fractured part of the vertebral body (hemicorporectomy) including the intervertebral disc segments. The resulting void is replaced by an (expandable) spacer/cage. |
|
| Non-surgical treatment | No Intervention | The patients will receive an external bracing (3-point hyperextension brace) for six weeks, which must be always worn except when lying flat in bed. The brace is adjusted by an experienced orthopedist. A physiotherapist will instruct the patient to accomplish daily activities with the restriction he or she will have by wearing the brace. | |
| Observational arm | Other | Patients who do not agree to randomization will be given the option to participate in the observational arm of the study. Their treatment will be surgical fixation with an anterior-posterior stabilization (as per our current internal hospital standard). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical stabilization | Procedure | Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation | ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life. | 2 years after fracture |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle | Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine | Pre-Treatment to 2 years after the fracture |
| Radiological outcome: Spinal fusion and fracture consolidation |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological outcome: Fracture comminution | Fracture comminution of the vertebral body | Pre-Treatment |
| Radiological outcome: Classification of traumatic disc injury | Sanders Classification |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph E Albers, PD Dr. | Contact | +41 (0) 31 664 04 40 | christoph.albers@insel.ch | |
| Sonja Häckel, Dr. | Contact | +41 (0) 31 664 04 40 | sonja.haeckel@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christoph E Albers, PD Dr. | Inselspital Bern, Department of Orthopaedic Surgery and Traumatology | Principal Investigator |
| Sonja Häckel, Dr. | Inselspital Bern, Department of Orthopaedic Surgery and Traumatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22057820 | Background | 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. | |
| 23970107 | Background | 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.0b013e3182a8a381. |
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No process has been defined yet how the sharing of the data should proceed
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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|
Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan |
| 26 weeks after fracture |
| Radiological outcome: Segment mobility | Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups | 52 weeks after fracture |
| Radiological outcome: Degeneration of the intervertebral disc over time | Degeneration of the intervertebral disc (Pfirrmann grade) | Pre-Treatment, 52 weeks after the fracture |
| Radiological outcome: Progression of spinal canal stenosis | Assessed on CT-scan and MRI | From the time of fracture, 26 weeks and 52 weeks |
| Non-surgical treatment failure rate | Proportion/frequency of patients in the non-surgery group that received surgery later, if there is a clinical indication (spinal instability measured by a kyphosis > 30 degrees on x-ray, intolerable pain, delayed onset of neurological symptoms) or if the patient is not satisfied after treatment | From the time of fracture to 2 years after the fracture |
| Complication rate and severity and additional surgeries | Rate and severity according to the Spine Adverse Events Severity System (SAVES) and surgical complications between treatment groups | 6, 12, 26, 52, and 104 weeks |
| Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST) | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | From the time of fracture to 2 years after the fracture |
| Changes in patient-related outcome measurements: EQ5D-3L | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | Pre-Treatment to 2 years after the fracture |
| Changes in patient-related outcome measurements: Pain visual analogue scale (VAS) | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | Pre-Treatment to 2 years after the fracture |
| Indirect costs | Assessed by indirect cost questionnaire and compared between treatment groups | 6, 12, 26, 52, and 104 weeks |
| Treatment data: Length of hospitalization (days) | Inhospital data records, comparison between treatment groups | Pre-Treatment to discharge from hospital |
| Treatment data: blood loss during surgery (ml) | Inhospital data records | during surgery |
| Treatment data: duration of surgery (hh: mm) | Inhospital data records | during surgery |
| Time to return to work/sports | Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups | 6, 12, 26, 52, and 104 weeks |
| Radiological outcome: Sagittal and coronal alignment | Assessed by long-standing x-rays of the entire spine, comparison between treatment groups | 6, 12, 26, 52, and 104 weeks |
| Opioid use | Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks | Pre-Treatment, 6, 12, 26, 52, and 104 weeks |
| Pre-treatment |
| Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen | Not yet recruiting | Sankt Gallen | 9007 | Switzerland |
|
| 20881467 | Background | 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. |
| 30479250 | Background | 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. |