Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

NCT05769114 | Recruiting DMC

• 1 other identifier: 2022-00662
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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:

1. 1.evaluate the clinical outcome (Oswestry Disability Index)
2. 2.evaluate the radiography result (restoration and maintenance of spinal alignment)
3. 3.determine the prevalence of complications

Conditions

SPINAL Fracture; Burst Fracture; Spinal Instability of Thoracolumbar Region

Keywords

Traumatic Thoracolumbar Spine Burst Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle

  Pre-Treatment to 2 years after the fracture

• Radiological outcome: Spinal fusion and fracture consolidation

  26 weeks after fracture

• Radiological outcome: Segment mobility

  52 weeks after fracture

• Radiological outcome: Degeneration of the intervertebral disc over time

  Pre-Treatment, 52 weeks after the fracture

• Radiological outcome: Progression of spinal canal stenosis

  From the time of fracture, 26 weeks and 52 weeks

Other Outcomes (2)

• Radiological outcome: Fracture comminution

  Pre-Treatment

• Radiological outcome: Classification of traumatic disc injury

  Pre-treatment

Study Arms (3)

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.

Procedure: Surgical stabilization

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).

Procedure: Surgical stabilization

Interventions

Surgical stabilization PROCEDURE

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

Also known as: 360°-Stabilization

Observational arm; Surgical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
• Informed consent for study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (2)

Inselspital

Bern, 3010, Switzerland

RECRUITING

Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

NOT YET RECRUITING

Related 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.

  PMID: 22057820 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.

  PMID: 23970107 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.

  PMID: 20881467 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.

  PMID: 30479250 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• 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

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 15, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)