Diagnostic Test Validity of Structural Vertebral Endplate Defects

Summary

Back pain is the most common cause of disability with a substantial burden on affected individuals, their families and society. Unfortunately, the causes of back pain are not well understood, hindering the development of effective prevention and treatment approaches. Until recently, the thin interface structure (endplate) between the vertebrae and the intervertebral disc has attracted attention as a possible contributor to back pain problems. However, the absence of clear descriptions for endplate defects has clouded associations with back pain and other imaging findings, which is problematic for measurement reliability. Thus, with CT, as with MRI, the varied measurement methods used to document the appearance of endplate defects on clinical imaging in the scientific literature, and the absence of validation of measurements of such methods leaves uncertainty about what the observations on clinical imaging actually represent.

Furthermore, Clinical CT is one of the most common imaging modalities used for the spine. On the other hand, Micro-CT, which produces accurate and reproducible measurements, has been used as a reference standard. The planned study will provide information that is critical for establishing meaningful standards for the evaluation and interpretation of endplate defects on clinical imaging, as well as for studies of their etiology and clinical consequences.

The study comprises 19 spines from 9 male and 10 female cadavers aged between 62 to 91 years from Western. Clinical-CT scans acquired on the cadavers will be assessed independently by two experienced imaging scientists (radiologists) and a graduate student studying endplate defects. A master's student in Clinical Anatomy has assessed and documented endplate defects on micro-CT, the reference standard. For the purpose of training and to identify practical issues in the evaluation process; four joint training sessions were organized for the raters to evaluate training sets of clinical CT images and discuss practical issues, using an evaluation manual consisting of measurement descriptions and figures. All the raters indicated satisfaction with the understanding and ability to use each measurement method. Thereafter, the three raters will independently assess the clinical CT for endplate defect presence, types, size and location. Endplate defects will be assessed with two weeks between measurements. Data will be imported into a secured computer for analysis.

Conditions

• Defect of Vertebral Endplate (Disorder)

Interventions

DIAGNOSTIC_TEST

clinical Computed Tomography

Clinical CT was acquired (scanned at 1.25mm x 1.25mm on a standard algorithm and then reformatted into an axial, coronal and sagittal series at 3mm x 2mm) on all fully intact cadavers prior to the onset of this study by the Schulich School of Medicine \& Dentistry at the University of Western Ontario, in accordance with the Anatomy Act of Ontario and guidelines of Western's Committee for Cadaveric Use in Research.

Sponsors & Collaborators

• London Health Sciences Centre

  collaborator OTHER

• Western University, Canada

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

62 Years

Max Age

91 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-17

Primary Completion

2021-05-25

Completion

2021-05-25

FDA Device

Yes

Countries

• Canada

Study Locations