Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

SPINAL Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769114
• Other study ID #: 2022-00662
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: March 2030

Study information

• Verified date: December 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Christoph E Albers, PD Dr.
• Phone: +41 (0) 31 664 04 40
• Email: christoph.albers[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 2030
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Burst Fracture
• Fractures, Bone
• SPINAL Fracture
• Spinal Fractures

Intervention

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

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern
Switzerland	Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiological outcome: Fracture comminution	Fracture comminution of the vertebral body	Pre-Treatment
Other	Radiological outcome: Classification of traumatic disc injury	Sanders Classification	Pre-treatment
Primary	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
Secondary	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
Secondary	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	26 weeks after fracture
Secondary	Radiological outcome: Segment mobility	Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups	52 weeks after fracture
Secondary	Radiological outcome: Degeneration of the intervertebral disc over time	Degeneration of the intervertebral disc (Pfirrmann grade)	Pre-Treatment, 52 weeks after the fracture
Secondary	Radiological outcome: Progression of spinal canal stenosis	Assessed on CT-scan and MRI	From the time of fracture, 26 weeks and 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Indirect costs	Assessed by indirect cost questionnaire and compared between treatment groups	6, 12, 26, 52, and 104 weeks
Secondary	Treatment data: Length of hospitalization (days)	Inhospital data records, comparison between treatment groups	Pre-Treatment to discharge from hospital
Secondary	Treatment data: blood loss during surgery (ml)	Inhospital data records	during surgery
Secondary	Treatment data: duration of surgery (hh: mm)	Inhospital data records	during surgery
Secondary	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
Secondary	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
Secondary	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