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Completed

NCT Number: NCT02719340

Short Segment Fixation in Thoracolumbar Osteoporotic Fracture

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.

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Key information

Conditions

Spinal Fractures Back Injuries Fractures, Bone Spinal Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

short segment fixation

Procedure

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

Primary outcomes

  1. The Oswestry Disability Index (ODI)

    Time frame: at least 2 years

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

Secondary outcomes

  1. Frankel's grade system

    Time frame: at least 2 years

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

  2. 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).

  3. anterior vertebral height

    Time frame: at least 2 years

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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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