Lumbar Spinal StenosisNCT03057353
Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients
An observational study of Lumbar Spinal Stenosis, run by Sixth Affiliated Hospital of Xinjiang Medical University.
Trial summary
To measure ligamentum flavum thickness in patients with different nationalities, sexes, heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore the correlation between various factors and ligamentum flavum thickness, provide reference for pedicle screw placement and lumbar… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- lumbar CT imaging
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2017
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 104 patients were evaluated after they signed the informed consent, including sex, age, height, nationality, weight, history of present illness, past history, family history, personal history, marital history, laboratory examination, and CT examination.
Who may be able to join
- Lumbar spinal stenosis revealed by Lumbar CT images
- Complained of low back pain
- Age between 45 and 80 years old
- Irrespective of sex
- Signed informed consent
Who cannot join
- Spinal injury
- Spinal tumor
- Spinal infection
- Congenital or acquired spine deformity
- Pulmonary tuberculosis
- Severe systemic disease such as malignant tumor
- Cannot cope with the doctor due to mental illness or other causes
About this study
Official title: Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients From Xinjiang Uygur Autonomous Region of China: a Retrospective, Single-center, Case Analysis
To measure ligamentum flavum thickness in patients with different nationalities, sexes, heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore the correlation between various factors and ligamentum flavum thickness, provide reference for pedicle screw placement and lumbar decompression surgery, develop individualized surgical programs, and can effectively reduce the incidence of unnecessary postoperative complications induced by misplacement.
Read the detailed description
History and current related studies With the increase of human social activities, spinal degenerative disease is increasing year by year. Due to the special anatomical structures and biomechanical characteristics, lumbar vertebrae easily suffer from lumbar spinal stenosis. Lumbar spinal stenosis is a medical condition in which the spinal canal narrows and compresses the spinal cord and nerves at the level of the lumbar vertebra. Vertebral spondylolisthesis, facet joint hyperplasia, bony spur posterior extension, intervertebral disc prolapse/protrusion, and ligamentum flavum hypertrophy are common causes for degenerative lumbar spinal stenosis, and ligamentum flavum hypertrophy is one of the important causes for spinal stenosis. When conservative treatment is ineffective, the occurrence of muscle paralysis or bladder symptoms caused by nerve compression requires surgical treatment. Commonly used surgical methods include pedicle screw fixation, flavectomy, laminectomy and facetectomy. Therefore, important anatomical structures will be involved in the operation, such as pedicle, ligamentum flavum, lamina, and articular process.
Many previous studies concern pedicle morphology, lumbar ligamentum flavum, lamina and articular process, and important reference data are listed in Table 1. Safak et al. verified that ligamenta flavum thickness was not associated with sex; ligamenta flavum was remarkably thicker on the left side of segments L4/5 and L5/S1 than that on the right side; ligamenta flavum thickness was not positively correlated with age. Few studies address whether ligamenta flavum thickness was associated with nationality, sex and obesity.
Data collection, management, analysis and open-access
- Written and electronic data were collected. The electronic data were stored in a specialized computer, and locked by the data manager. The written data were stored and locked in a reference room. The key was kept by the data manager and laboratory manager.
- The locked database was not altered and was preserved, along with the original records. The database was statistically analyzed by a professional statistician.
- Prior to any analysis of the data, the analysis plan outlined in this section would be reviewed, and detailed statistical analysis plans would be prepared and approved. All data regarding this trial were preserved by the Sixth Affiliated Hospital, Xinjiang Medical University, China.
- Anonymized trial data would be published at www.figshare.com.
Statistical analysis
- All data were analyzed using SPSS 21.0 software (IBM, Armonk, NY, USA).
- All measurement data were normally distributed and expressed as mean ± standard deviation.
- Ligamentum flavum thickness was compared among groups using two-sample t-test or one-way analysis of variance. Paired comparison between groups was conducted using Student-Newman-Keuls test. Correlation of nationality, sex, height, age and weight with ligamentum flavum thickness was analyzed using Pearson's correlation coefficient. Risk factors for ligamentum flavum hypertrophy were analyzed using multiple linear regression analysis. Odd ratio and 95% confidence interval were calculated.
- The significance level was α = 0.05.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- lumbar CT imaging
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar CT imagingDevice
Collecting lumbar CT imaging data of 104 patients with lumbar spinal stenosis to observed the incidence of ligamentum flavum hypertrophy of patients with different nationalities, sexes, heights, ages, and weights and explored risk factors affecting ligamentum flavum hypertrophy.
| Study group | Role | What they receive |
|---|---|---|
| lumbar CT imaging | Collecting lumbar CT imaging data of 104 patients with lumbar spinal stenosis to observed the incidence of ligamentum flavum hypertrophy of patients with different nationalities, sexes, heights, ages, and weights and explored risk factors affecting ligamentum flavum hypertrophy. Receives: Device: lumbar CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligamentum flavum thickness
Changes in ligamentum flavum thickness were observed under different influential factors.
Measured: from May 2012 to May 2016
Secondary outcomes (1)
Lumbar morphology of patients
Changes in ligamentum flavum morphology.
Measured: from May 2012 to May 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startMay 2012
- Primary completionMay 2016
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Zhou, Sixth Affiliated Hospital of Xinjiang Medical University
- Investigators
- Gang Zhou, Master, Principal investigator, Sixth Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057353
- Sponsor's protocol ID
- SixthAHXinjiang_01
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients From Xinjiang Uygur Autonomous Region of China: a Retrospective, Single-center, Case Analysis
- ClinicalTrials.gov ID
- NCT03057353
- Acronym / sponsor ID
- SixthAHXinjiang_01
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Feb 2017 (actual)
- 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.
To measure ligamentum flavum thickness in patients with different nationalities, sexes, heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore the correlation between various factors and ligamentum flavum thickness, provide reference for pedicle screw placement and lumbar decompression surgery, develop individualized surgical programs, and can effectively reduce the incidence of unnecessary postoperative complications induced by misplacement.
Detailed description
History and current related studies With the increase of human social activities, spinal degenerative disease is increasing year by year. Due to the special anatomical structures and biomechanical characteristics, lumbar vertebrae easily suffer from lumbar spinal stenosis. Lumbar spinal stenosis is a medical condition in which the spinal canal narrows and compresses the spinal cord and nerves at the level of the lumbar vertebra. Vertebral spondylolisthesis, facet joint hyperplasia, bony spur posterior extension, intervertebral disc prolapse/protrusion, and ligamentum flavum hypertrophy are common causes for degenerative lumbar spinal stenosis, and ligamentum flavum hypertrophy is one of the important causes for spinal stenosis. When conservative treatment is ineffective, the occurrence of muscle paralysis or bladder symptoms caused by nerve compression requires surgical treatment. Commonly used surgical methods include pedicle screw fixation, flavectomy, laminectomy and facetectomy. Therefore, important anatomical structures will be involved in the operation, such as pedicle, ligamentum flavum, lamina, and articular process.
Many previous studies concern pedicle morphology, lumbar ligamentum flavum, lamina and articular process, and important reference data are listed in Table 1. Safak et al. verified that ligamenta flavum thickness was not associated with sex; ligamenta flavum was remarkably thicker on the left side of segments L4/5 and L5/S1 than that on the right side; ligamenta flavum thickness was not positively correlated with age. Few studies address whether ligamenta flavum thickness was associated with nationality, sex and obesity.
Data collection, management, analysis and open-access
- Written and electronic data were collected. The electronic data were stored in a specialized computer, and locked by the data manager. The written data were stored and locked in a reference room. The key was kept by the data manager and laboratory manager.
- The locked database was not altered and was preserved, along with the original records. The database was statistically analyzed by a professional statistician.
- Prior to any analysis of the data, the analysis plan outlined in this section would be reviewed, and detailed statistical analysis plans would be prepared and approved. All data regarding this trial were preserved by the Sixth Affiliated Hospital, Xinjiang Medical University, China.
- Anonymized trial data would be published at www.figshare.com.
Statistical analysis
- All data were analyzed using SPSS 21.0 software (IBM, Armonk, NY, USA).
- All measurement data were normally distributed and expressed as mean ± standard deviation.
- Ligamentum flavum thickness was compared among groups using two-sample t-test or one-way analysis of variance. Paired comparison between groups was conducted using Student-Newman-Keuls test. Correlation of nationality, sex, height, age and weight with ligamentum flavum thickness was analyzed using Pearson's correlation coefficient. Risk factors for ligamentum flavum hypertrophy were analyzed using multiple linear regression analysis. Odd ratio and 95% confidence interval were calculated.
- The significance level was α = 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lumbar CT imaging | – | Device: lumbar CT imagingCollecting lumbar CT imaging data of 104 patients with lumbar spinal stenosis to observed the incidence of ligamentum flavum hypertrophy of patients with different nationalities, sexes, heights, ages, and weights and explored risk factors affecting ligamentum flavum hypertrophy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 104 patients were evaluated after they signed the informed consent, including sex, age, height, nationality, weight, history of present illness, past history, family history, personal history, marital history, laboratory examination, and CT examination.
Key inclusion criteria (5 listed)
- Lumbar spinal stenosis revealed by Lumbar CT images
- Complained of low back pain
- Age between 45 and 80 years old
- Irrespective of sex
- Signed informed consent
Key exclusion criteria (7 listed)
- Spinal injury
- Spinal tumor
- Spinal infection
- Congenital or acquired spine deformity
- Pulmonary tuberculosis
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 |
|---|---|---|
| lumbar CT imagingCollecting lumbar CT imaging data of 104 patients with lumbar spinal stenosis to observed the incidence of ligamentum flavum hypertrophy of patients with different nationalities, sexes, heights, ages, and weights and explored risk factors affecting ligamentum flavum hypertrophy. | Device | lumbar CT imaging |
Primary outcome
Ligamentum flavum thickness
Time frame: from May 2012 to May 2016
Changes in ligamentum flavum thickness were observed under different influential factors.
1 secondary outcome
Lumbar morphology of patients
Time frame: from May 2012 to May 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Gang Zhou, Master principal investigator
Sixth Affiliated Hospital of Xinjiang Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Sixth Affiliated Hospital of Xinjiang Medical University.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. 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?
Results are not available in the source record.
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?
Ligamentum flavum thickness (time frame: from May 2012 to May 2016). 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 20 Feb 2017.