COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057353
Recruitment Status : Unknown
Verified February 2017 by Gang Zhou, Sixth Affiliated Hospital of Xinjiang Medical University.
Recruitment status was:  Active, not recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Gang Zhou, Sixth Affiliated Hospital of Xinjiang Medical University

Brief 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 decompression surgery, develop individualized surgical programs, and can effectively reduce the incidence of unnecessary postoperative complications induced by misplacement.

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Device: lumbar CT imaging

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

  1. 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.
  2. The locked database was not altered and was preserved, along with the original records. The database was statistically analyzed by a professional statistician.
  3. 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.
  4. Anonymized trial data would be published at www.figshare.com.

Statistical analysis

  1. All data were analyzed using SPSS 21.0 software (IBM, Armonk, NY, USA).
  2. All measurement data were normally distributed and expressed as mean ± standard deviation.
  3. 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.
  4. The significance level was α = 0.05.

Layout table for study information
Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : May 2012
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: 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.




Primary Outcome Measures :
  1. Ligamentum flavum thickness [ Time Frame: from May 2012 to May 2016 ]
    Changes in ligamentum flavum thickness were observed under different influential factors.


Secondary Outcome Measures :
  1. Lumbar morphology of patients [ Time Frame: from May 2012 to May 2016 ]
    Changes in ligamentum flavum morphology.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057353


Sponsors and Collaborators
Sixth Affiliated Hospital of Xinjiang Medical University
Investigators
Layout table for investigator information
Principal Investigator: Gang Zhou, Master Sixth Affiliated Hospital of Xinjiang Medical University
Layout table for additonal information
Responsible Party: Gang Zhou, Attending Physician, Sixth Affiliated Hospital of Xinjiang Medical University
ClinicalTrials.gov Identifier: NCT03057353    
Other Study ID Numbers: SixthAHXinjiang_01
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Constriction, Pathologic
Hypertrophy
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases