NCT02963571

Brief Summary

To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 10, 2016

Last Update Submit

November 10, 2016

Conditions

Vertebral Fracture

Outcome Measures

Primary Outcomes (1)

  • The Cobb angle of the injured vertebral body

    To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.

    before, immediately after, and 3 months after surgery

Secondary Outcomes (2)

  • Anterior height of the injured vertebral body

    before, immediately after, and 3 months after surgery

  • X-ray

    before, immediately after, and 3 months after surgery

Study Arms (1)

screw fixation

EXPERIMENTAL

The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation.

Procedure: posterior percutaneous pedicle screw internal fixation

Interventions

posterior percutaneous pedicle screw internal fixationPROCEDURE

The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

screw fixation

Eligibility Criteria

Age25 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet the diagnostic criteria of acute thoracolumbar vertebral fracture with simple anterior spinal column injury as confirmed by radiography, CT and MRI
  • AO classification type A
  • Thoracolumbar injury severity score of 4-5 (Park et al., 2016)
  • Traumatic fracture
  • Age 25-47 years

You may not qualify if:

  • Fracture complicated by spinal cord injury
  • Fracture complicated by nerve injury
  • Refusal to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Lei Liang, Master

    PLA 153 Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

August 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2014

Last Updated

November 15, 2016

Record last verified: 2016-11