Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

NCT ID: NCT05769114

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2030-03-31

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. 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.

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.

Conditions

SPINAL Fracture; Burst Fracture; Spinal Instability of Thoracolumbar Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical treatment

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.

Group Type: ACTIVE_COMPARATOR

Surgical stabilization

Intervention Type: PROCEDURE

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

Non-surgical treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Observational arm

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).

Group Type: OTHER

Surgical stabilization

Intervention Type: PROCEDURE

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

Interventions

Surgical stabilization

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

Intervention Type: PROCEDURE

Other Intervention Names

360°-Stabilization

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital St. Gallen, St. Gallen, Switzerland

UNKNOWN

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph E Albers, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Inselspital Bern, Department of Orthopaedic Surgery and Traumatology

Sonja Häckel, Dr.

Role: STUDY_DIRECTOR

Inselspital Bern, Department of Orthopaedic Surgery and Traumatology

Locations

Inselspital

Bern, , Switzerland

Site Status: RECRUITING

Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Central Contacts

Christoph E Albers, PD Dr.

Role: CONTACT

christoph.albers@insel.ch

+41 (0) 31 664 04 40

Sonja Häckel, Dr.

Role: CONTACT

sonja.haeckel@insel.ch

+41 (0) 31 664 04 40

Facility Contacts

Sonja Häckel, MD

Role: primary

Sonja.haeckel@insel.ch

+41 (0) 31 664 04 40

Veronique Vogel

Role: backup

veronique.vogel@insel.ch

+41 (0) 31 632 42 42

Martin Stienen, PD Dr.

Role: primary

oswz@kssg.ch

+41 71 494 77 77

References

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.

Reference Type: BACKGROUND

PMID: 22057820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23970107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20881467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30479250 (View on PubMed)

Other Identifiers

2022-00662

Identifier Type: -

Identifier Source: org_study_id