Short Segment Fixation in Thoracolumbar Osteoporotic Fracture

March 21, 2016 updated by: Cheng-Li Lin, National Cheng-Kung University Hospital

Short-segment Decompression and Reconstruction for Thoracolumbar Osteoporotic Fractures With Neurological Deficits: Clinical and Radiological Results of Minimum 2-year Follow-up

Although long-segment posterior spinal fixation might provide more rigid fixation, the procedure increases perioperative morbidities in the elderly. The present study reviews the results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study included 20 elderly patients with osteoporotic thoracolumbar burst fractures and neurological compromise. The participants were followed-up for a period of 40.6 (24-68) months. A visual analog scale (VAS) and the Oswestry Disability Index (ODI) were used to measure back pain and disability. Radiologic assessment and neurological status were also analyzed.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Twenty elderly patients (60-89 years, mean 73.2 years) with osteoporotic thoracolumbar burst fractures and neurological compromise

Description

Inclusion Criteria

  • osteoporotic burst fracture at a single level of the thoracolumbar region
  • dual-energy X-ray absorptiometry and T-score value less than -2.5

Exclusion Criteria

  • translational displacement at the fracture site (fracture-dislocation)
  • loss of structural integrity within the posterior osteoligamentous complex (such as flexion-distraction ligament disruption)
  • spondylolisthesis of the adjacent vertebrae
  • malignancy
  • chronic steroid administration
  • previous spinal surgery
  • prior vertebroplasty and infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Oswestry Disability Index (ODI)
Time Frame: at least 2 years
Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)
at least 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frankel's grade system
Time Frame: at least 2 years
Frankel's grade system was used for assessment of neurologic function
at least 2 years
Local kyphosis and vertebral wedge angle were measured as radiologic assessment (units of measure: degree)
Time Frame: at least 2 years
Digital radiographs of the vertebral bodies were reviewed using the picture archiving and communication system (PACS).
at least 2 years
anterior vertebral height
Time Frame: at least 2 years
Measurements of the anterior vertebral height (AVH) ratio (% of normal)
at least 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SSF-TLF-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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