Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

NCT02950532 | Completed

• 1 other identifier: AOCID_PAM
• Study Type: observational
• Target: 60
• Locations: 5 countries
• Sites: 5

Brief Summary

The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI)

Conditions

Spinal Deformity; Spinal Fractures; Spinal Injuries; Kyphosis

Keywords

Posterior ligamentous complex; Thoracolumbar fractures; Interspinous distance; Local kyphosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)

  Sensitivity of LK and/or ISD Is defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The Specificity si defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The gold standard is a diagnostic test and it is the best accepted test that is assumed to be able to determine the true disease state. It is considered as the reference method or the best test available.

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

Secondary Outcomes (3)

• Sensitivity and specificity of superior-inferior end plate angle (SIEA)

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

• Sensitivity and specificity of vertebral body height (BH)

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

• Sensitivity and specificity of inter-pedicular distance (IPD)

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

Other Outcomes (2)

• Accuracy of CT scan measurements

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

• Inter-rater reliability

  CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).

Study Arms (1)

Cases

Retrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury

Other: Retrospective radiological evaluation

Interventions

Retrospective radiological evaluation OTHER

Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).

Cases

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The participating study sites will retrospectively identify all eligible patients in the medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If required by local regulations, patients choosing to participate will sign and date an informed consent form (ICF).

You may qualify if:

• Age 18 to 60 years
• A3/A4 TL fracture between T11-L2 with or without PLC injury
• Pre-treatment CT scan and MRI. Radiographs (if available)
• Signed Informed consent, if required by EC/IRB

You may not qualify if:

• Pathological fractures
• Multilevel contiguous and non-contiguous injuries
• Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries
• Fractures with translation injuries or dislocations such as AO type C injuries

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (5)

The 1st Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Assiut Universtiy Hospitals

Asyut, 71526, Egypt

Location

Ganga Hospital

Coimbatore, 641 011, India

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, 118765, South Korea

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Spinal Fractures; Spinal Injuries; Kyphosis

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Fractures, Bone; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Shanmuganathan Rajasekaran, Prof. MD

  Ganga Hospital

  PRINCIPAL INVESTIGATOR

• Test Testing, MD

  TESTING

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

GB (1); EG (1); IN (1); KR (1); CN (1)