Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients

NCT03057353 | Unknown DMC FDA Device

• 1 other identifier: SixthAHXinjiang_01
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Ligamentum flavum thickness

  Changes in ligamentum flavum thickness were observed under different influential factors.

  from May 2012 to May 2016

Secondary Outcomes (1)

• Lumbar morphology of patients

  from May 2012 to May 2016

Study Arms (1)

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

Interventions

lumbar CT imaging DEVICE

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.

lumbar CT imaging

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital of Xinjiang Medical University: lead

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Gang Zhou, Master

  Sixth Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: May 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 20, 2017

Record last verified: 2017-02