- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02719340
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
Additional Relevant MeSH Terms
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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