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CompletedNCT02719340Updated Mar 25, 2016

Short Segment Fixation in Thoracolumbar Osteoporotic Fracture

An observational study in Spinal Fractures, sponsored by National Cheng-Kung University Hospital. Completed. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Ages
60 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

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In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • Procedureshort segment fixation

    posterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion)

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What researchers measure

Primary outcomes

  1. The Oswestry Disability Index (ODI)

    Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)

    Time frame: at least 2 years

Secondary outcomes

  1. Frankel's grade system

    Frankel's grade system was used for assessment of neurologic function

    Time frame: at least 2 years

  2. Local kyphosis and vertebral wedge angle were measured as radiologic assessment (units of measure: degree)

    Digital radiographs of the vertebral bodies were reviewed using the picture archiving and communication system (PACS).

    Time frame: at least 2 years

  3. anterior vertebral height

    Measurements of the anterior vertebral height (AVH) ratio (% of normal)

    Time frame: at least 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02719340
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Cheng-Li Lin (Attending Physician, National Cheng-Kung University Hospital) — Principal investigator
First posted
Mar 25, 2016
Start date
Nov 2010
Primary completion
Oct 2011
Completion
Dec 2012
Last update
Mar 25, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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