Spinal FracturesNCT02719340
Short Segment Fixation in Thoracolumbar Osteoporotic Fracture
An observational study of Spinal Fractures, run by National Cheng-Kung University Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- short segment fixation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty elderly patients (60-89 years, mean 73.2 years) with osteoporotic thoracolumbar burst fractures and neurological compromise
Who may be able to join
- osteoporotic burst fracture at a single level of the thoracolumbar region
- dual-energy X-ray absorptiometry and T-score value less than -2.5
Who cannot join
- 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
About this study
Official title: 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.
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.
- Conditions
- Spinal Fractures
- Being tested
- short segment fixation
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short segment fixationProcedure or surgery
posterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion)
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oswestry Disability Index (ODI)
Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)
Measured: at least 2 years
Secondary outcomes (3)
Frankel's grade system
Frankel's grade system was used for assessment of neurologic function
Measured: at least 2 years
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).
Measured: at least 2 years
anterior vertebral height
Measurements of the anterior vertebral height (AVH) ratio (% of normal)
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Li Lin, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719340
- Sponsor's protocol ID
- SSF-TLF-103
- Status last verified
- Mar 2016
- First submitted
- 18 Feb 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-segment Decompression and Reconstruction for Thoracolumbar Osteoporotic Fractures With Neurological Deficits: Clinical and Radiological Results of Minimum 2-year Follow-up
- ClinicalTrials.gov ID
- NCT02719340
- Acronym / sponsor ID
- SSF-TLF-103
- Conditions
- Spinal Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty elderly patients (60-89 years, mean 73.2 years) with osteoporotic thoracolumbar burst fractures and neurological compromise
Key inclusion criteria (2 listed)
- osteoporotic burst fracture at a single level of the thoracolumbar region
- dual-energy X-ray absorptiometry and T-score value less than -2.5
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short segment fixationposterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion) | Procedure or surgery | – |
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: at least 2 years
Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)
3 secondary outcomes
Frankel's grade system
Time frame: 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
anterior vertebral height
Time frame: at least 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fractures, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oswestry Disability Index (ODI) (time frame: at least 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.