Spinal Deformity Clinical Trial
— PAMOfficial title:
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity
NCT number | NCT02950532 |
Other study ID # | AOCID_PAM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | June 2018 |
Verified date | August 2020 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | The 1st Affiliated Hospital of Zhejiang University | Hangzhou | |
Egypt | Assiut Universtiy Hospitals | Assiut | |
India | Ganga Hospital | Coimbatore | |
Korea, Republic of | Uijeongbu St. Mary's Hospital | Uijeongbu-si | |
United Kingdom | Royal Victoria Hospital | Belfast |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Publishing Documentation |
China, Egypt, India, Korea, Republic of, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accuracy of CT scan measurements | Accuracy describes how closely the measured value is to the true value and is an indicator of systematic errors. The accuracy of measurements of each CT scan parameter will be compared between the participating sites. | 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 | Inter-rater reliability | The inter-rater reliability is defined as the percent agreement between the measurements of the different parameters by the different observers. The CT scans and radiographs (if available) distributed to the participating sites will be measured at each site by all participating MDs within each team or at least by one trained PI. | 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). | |
Primary | 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 | Sensitivity and specificity of superior-inferior end plate angle (SIEA) | Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in SIEA compared to MRI. | 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 | Sensitivity and specificity of vertebral body height (BH) | Is defined as the proportion of patients with PLC injury correctly diagnosed by an decrease in BH compared to MRI. | 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 | Sensitivity and specificity of inter-pedicular distance (IPD) | Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in IPD compared to MRI. | 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). |
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