Back to resultsSurgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture (A34RCT)
Primary Purpose
SPINAL Fracture, Burst Fracture, Spinal Instability of Thoracolumbar Region
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Surgical stabilization
Sponsored by
About this trial
This is an interventional treatment trial for SPINAL Fracture focused on measuring Traumatic Thoracolumbar Spine Burst Fracture
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
Other
Arm Label
Surgical treatment
Non-surgical treatment
Observational arm
Arm Description
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.
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.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Radiological outcome: Spinal fusion and fracture consolidation
Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan
Radiological outcome: Segment mobility
Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups
Radiological outcome: Degeneration of the intervertebral disc over time
Degeneration of the intervertebral disc (Pfirrmann grade)
Radiological outcome: Progression of spinal canal stenosis
Assessed on CT-scan and MRI
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
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
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
Changes in patient-related outcome measurements: EQ5D-3L
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
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
Indirect costs
Assessed by indirect cost questionnaire and compared between treatment groups
Treatment data: Length of hospitalization (days)
Inhospital data records, comparison between treatment groups
Treatment data: blood loss during surgery (ml)
Inhospital data records
Treatment data: duration of surgery (hh: mm)
Inhospital data records
Time to return to work/sports
Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups
Radiological outcome: Sagittal and coronal alignment
Assessed by long-standing x-rays of the entire spine, comparison between treatment groups
Opioid use
Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks
Full Information
NCT ID
NCT05769114
First Posted
February 8, 2023
Last Updated
October 23, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05769114
Brief Title
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
Acronym
A34RCT
Official Title
Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
evaluate the clinical outcome (Oswestry Disability Index)
evaluate the radiography result (restoration and maintenance of spinal alignment)
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SPINAL Fracture, Burst Fracture, Spinal Instability of Thoracolumbar Region
Keywords
Traumatic Thoracolumbar Spine Burst Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-surgical treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Observational arm
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Surgical stabilization
Other Intervention Name(s)
360°-Stabilization
Intervention Description
Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage
Primary Outcome Measure Information:
Title
The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
Description
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.
Time Frame
2 years after fracture
Secondary Outcome Measure Information:
Title
Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle
Description
Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine
Time Frame
Pre-Treatment to 2 years after the fracture
Title
Radiological outcome: Spinal fusion and fracture consolidation
Description
Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan
Time Frame
26 weeks after fracture
Title
Radiological outcome: Segment mobility
Description
Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups
Time Frame
52 weeks after fracture
Title
Radiological outcome: Degeneration of the intervertebral disc over time
Description
Degeneration of the intervertebral disc (Pfirrmann grade)
Time Frame
Pre-Treatment, 52 weeks after the fracture
Title
Radiological outcome: Progression of spinal canal stenosis
Description
Assessed on CT-scan and MRI
Time Frame
From the time of fracture, 26 weeks and 52 weeks
Title
Non-surgical treatment failure rate
Description
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
Time Frame
From the time of fracture to 2 years after the fracture
Title
Complication rate and severity and additional surgeries
Description
Rate and severity according to the Spine Adverse Events Severity System (SAVES) and surgical complications between treatment groups
Time Frame
6, 12, 26, 52, and 104 weeks
Title
Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST)
Description
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Time Frame
From the time of fracture to 2 years after the fracture
Title
Changes in patient-related outcome measurements: EQ5D-3L
Description
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Time Frame
Pre-Treatment to 2 years after the fracture
Title
Changes in patient-related outcome measurements: Pain visual analogue scale (VAS)
Description
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Time Frame
Pre-Treatment to 2 years after the fracture
Title
Indirect costs
Description
Assessed by indirect cost questionnaire and compared between treatment groups
Time Frame
6, 12, 26, 52, and 104 weeks
Title
Treatment data: Length of hospitalization (days)
Description
Inhospital data records, comparison between treatment groups
Time Frame
Pre-Treatment to discharge from hospital
Title
Treatment data: blood loss during surgery (ml)
Description
Inhospital data records
Time Frame
during surgery
Title
Treatment data: duration of surgery (hh: mm)
Description
Inhospital data records
Time Frame
during surgery
Title
Time to return to work/sports
Description
Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups
Time Frame
6, 12, 26, 52, and 104 weeks
Title
Radiological outcome: Sagittal and coronal alignment
Description
Assessed by long-standing x-rays of the entire spine, comparison between treatment groups
Time Frame
6, 12, 26, 52, and 104 weeks
Title
Opioid use
Description
Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks
Time Frame
Pre-Treatment, 6, 12, 26, 52, and 104 weeks
Other Pre-specified Outcome Measures:
Title
Radiological outcome: Fracture comminution
Description
Fracture comminution of the vertebral body
Time Frame
Pre-Treatment
Title
Radiological outcome: Classification of traumatic disc injury
Description
Sanders Classification
Time Frame
Pre-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph E Albers, PD Dr.
Phone
+41 (0) 31 664 04 40
Email
christoph.albers@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Häckel, Dr.
Phone
+41 (0) 31 664 04 40
Email
sonja.haeckel@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph E Albers, PD Dr.
Organizational Affiliation
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonja Häckel, Dr.
Organizational Affiliation
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
Official's Role
Study Director
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Häckel, MD
Phone
+41 (0) 31 664 04 40
Email
Sonja.haeckel@insel.ch
First Name & Middle Initial & Last Name & Degree
Veronique Vogel
Phone
+41 (0) 31 632 42 42
Email
veronique.vogel@insel.ch
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No process has been defined yet how the sharing of the data should proceed
Citations:
PubMed Identifier
22057820
Citation
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.
Results Reference
background
PubMed Identifier
23970107
Citation
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.
Results Reference
background
PubMed Identifier
20881467
Citation
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.
Results Reference
background
PubMed Identifier
30479250
Citation
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.
Results Reference
background
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Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
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