NCT02827214

Brief Summary

Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
10 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

5.3 years

First QC Date

May 23, 2016

Last Update Submit

January 30, 2023

Conditions

Thoracolumbar Burst Fracture

Keywords

Thoracolumbar spineBurst fracturesConservative treatmentSurgical treatmentThoracic or lumbar vertebrae

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    ODI within the first year after surgical or non-surgical treatment using time to event analysis

    1 year

Secondary Outcomes (9)

  • AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)

    2 years

  • Quality of life EQ5D-3L

    2 years

  • Numeric Pain Rating Scale (NPRS)

    2 years

  • Spine Adverse Events Severity System (SAVES)

    2 years

  • overall satisfaction with the treatment

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Surgical treatment

Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail Approaches: * Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression * Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression * Posterior short or long fixation with posterolateral corpectomy and reconstruction * Anterior alone instrumentation * Combined Anterior Posterior (AP) instrumentation * Percutaneous posterior fixation combined with anterior instrumentation * Percutaneous posterior fixation with or without vertebroplasty

Non-surgical treatment

Non-surgical treatment is defined as bed rest followed by immobilization with: * Custom-molded or prefabricated total body contact thoracolumbosacral orthosis (TLSO) * Thermoplastic removable brace * Jewett hyperextension braces * Anterior hyperextension brace (ASH) * Taylor-Knight brace * Plaster of Paris (POP)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thoracolumbar burst fractures

You may qualify if:

  • Skeletally mature, age 18 to 65 years old inclusive
  • Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC injury (M1) from T10 to L2.
  • Patients may have an associated B injury, but must have an A3 or A4.
  • TLICS Score between 2-5 inclusive
  • Acute fracture - diagnosis and treatment within 10 days of injury
  • Ability to understand the content of the patient information / informed consent form
  • Willingness and ability to participate in the clinical investigation including imaging and FU procedures
  • Investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated IRB/EC-approved written informed consent

You may not qualify if:

  • Any neurological deficit associated with the fracture. Absence of neurological deficit will be determined with the International Standards for Neurological Classification of Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically intact/normal) of the patient.
  • Spontaneous fractures due to pathologic processes or neoplasia
  • Head injuries causing inability to cooperate during hospital admission
  • Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
  • Prior spinal surgeries in thoracic or lumbar spine
  • Additional musculoskeletal, head or other injuries which would preclude rapid mobilization
  • Multiple trauma or Injury Severity Score (ISS) \> 16
  • Other co-morbidities precluding the patient to be considered as a surgical or non-surgical candidate, i.e. burns, dementia, BMI \> 40, etc.
  • Any severe systemic medical disease that would exclude the patient to be a potential candidate for surgery
  • Prisoner
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
  • Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment.
  • Pregnancy or women planning to conceive within the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of California, San Diego Medical Center

San Diego, California, 92093, United States

Location

SUNY Upstate

East Syracuse, New York, 13057, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

West Virginia University

Morgantown, West Virginia, 26506-9496, United States

Location

Alfred Health operating through the Alfred hospital

Melbourne, 3004, Australia

Location

Hopital l'Enfant-Jesus, CHU de Quebec

Québec, 1401, Canada

Location

Vancouver General Hospital

Vancouver, V5z1M9, Canada

Location

Assiut University Hospitals

Asyut, 71526, Egypt

Location

KAT Hospital

Kifissia, 145 61, Greece

Location

Ganga Hospital

Coimbatore, 641011, India

Location

UMC Utrecht

Utrecht, 3508 AB, Netherlands

Location

Clinical Hospital "Prof. N.Oblu"

Iași, Romania

Location

Hospital Universitario Costa del Sol

Marbella, 29603, Spain

Location

Inselspital, University of Bern

Bern, 3010, Switzerland

Location

Related Links

Study Officials

  • Marcel Dvorak, MD

    Vancouver General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

July 11, 2016

Study Start

October 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)IN(1)AU(1)CA(2)RO(1)ES(1)NL(1)GR(1)EG(1)CH(1)