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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02995798
Other study ID # Anatomy C-Spine
Secondary ID
Status Completed
Phase N/A
First received December 9, 2016
Last updated December 14, 2016
Start date April 2009
Est. completion date August 2016

Study information

Verified date December 2016
Source Gangneung Asan Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Gangneung Asan Hospital Institutional Review Board
Study type Observational

Clinical Trial Summary

Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April 2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score ≥-1; Group B, -2.5<T-score<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients, Group B had lower normal patients including osteopenic patients and Group C presented osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU, the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the axial CT images in clinical images.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date August 2016
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years and older
Eligibility Inclusion Criteria:

- Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)

Exclusion Criteria:

- Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Cortical Bone thickness and Hounsfield unit (HU) numbers
Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD

Locations

Country Name City State
Korea, Republic of Moon-Kyu Kim Gangneung Kangwondo

Sponsors (2)

Lead Sponsor Collaborator
Gangneung Asan Hospital The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cortical bone Thickness two weeks No
Primary HU number two weeks No