Ignite Creation Date:
2024-05-05 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00782223
Status:
UNKNOWN
Last Update Posted:
2008-10-31
First Post:
2008-10-29
Brief Title:
Assessment of Digital Radiograph Measurements of HipSpine and Lower Limbs
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Assessment of Hip Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population Using PACS Integrated Computer Software TraumaCad From OrthoCrat
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research Protocol Assessment of Hip Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population using PACS integrated Computer Software TraumaCad from OrthoCrat
Introduction The integration of the PACS system into many medical institutions created a plethora of digital measurements to assess anatomic and deformity parameters for torso and limbs
A number of commercial digital software is being offered to supply the medical practioner with tools to assess normal and pathological bony architecture land marks
The relevant architecture of the pelvis hip joint spine and the length and alignment of lower limbs may be measured using these digital softwares
The validity and accuracy of digital work in comparison to conventional radiographs has been studied recently mainly with lower extremity axial alignment the digital length and anatomical angles measurements were found to be more reliable in terms of intra observer reliability than conventional radiographs 1 2
Study purposes
1 To compare the accuracy and reliability of specifically designed digital software TraumaCad from OrthoCrat measurements using wizard guidance to those produced by using the tool bar ruler and angle guide tools of the DICOM folder
2 To assess intra and inter observer reliability of the TraumaCad software for different pediatric orthopaedics conditions
Methods Twenty hip joins radiographs AP views of patients who suffer from Cerebral Palsy 10 and Developmental Dysplasia of the Hip 10 will be measured using the TraumaCad software hip joint wizard and than again using basic tools of the DICOM folder
Twenty spinal scoliosis radiographs AP and Lat views will be measured using the TraumaCad software templates
Ten digital radiographs of long leg standing AP views from normal and from patients with deformities will ne analyzed for length and angular differences using the LLD wizard
The following parameters will be measured Hip joint radiographs Acetabular Angle Central Edge Angle and Reimers Index Spinal radiographs Cobe Angle AP views Coronal Balance Sagital Balance Long standing views length of Femur and Tibia mLDFA mMPTA mLDTA JLCA the Baltimore numbers
All measurements will be taken by 4 senior orthopaedic surgeons after consensus conference for the technique
Intra observer reliability will be tested by repeating the same set of measurements on 2 different dates after all radiographs are randomly mixed and done at least 2 days apart High resolution single computer will be used for all measurements by all participating surgeons
The intra and inter observer reliability for the hip joint measurements will be calculate to compared between TraumaCad software wizard and the DICOM measurements tools
All measurements using TraumaCad software will be analyzed for intra and inter observer reliability using accepted statistical tools
The study will be supervised by the department of statistics of TAU for maximum statistical significance
1 Sailer J Scharitzer M Peloschek P Giurea A Imhof H Grampp S
Quantification of axial alignment of the lower extremity on conventional and digital total leg radiographs
Eur Radiol 2005 Jan 151170-3 Epub 2004 Aug 5
2 Hankemeier S Gosling T Richter M Hufner T Hochhausen C Krettek C
Computer-assisted analysis of lower limb geometry higher intraobserver reliability compared to conventional method
Comput Aided Surg 2006 Mar 11281-6
Introduction The integration of the PACS system into many medical institutions created a plethora of digital measurements to assess anatomic and deformity parameters for torso and limbs
A number of commercial digital software is being offered to supply the medical practioner with tools to assess normal and pathological bony architecture land marks
The relevant architecture of the pelvis hip joint spine and the length and alignment of lower limbs may be measured using these digital softwares
The validity and accuracy of digital work in comparison to conventional radiographs has been studied recently mainly with lower extremity axial alignment the digital length and anatomical angles measurements were found to be more reliable in terms of intra observer reliability than conventional radiographs 1 2
Study purposes
1 To compare the accuracy and reliability of specifically designed digital software TraumaCad from OrthoCrat measurements using wizard guidance to those produced by using the tool bar ruler and angle guide tools of the DICOM folder
2 To assess intra and inter observer reliability of the TraumaCad software for different pediatric orthopaedics conditions
Methods Twenty hip joins radiographs AP views of patients who suffer from Cerebral Palsy 10 and Developmental Dysplasia of the Hip 10 will be measured using the TraumaCad software hip joint wizard and than again using basic tools of the DICOM folder
Twenty spinal scoliosis radiographs AP and Lat views will be measured using the TraumaCad software templates
Ten digital radiographs of long leg standing AP views from normal and from patients with deformities will ne analyzed for length and angular differences using the LLD wizard
The following parameters will be measured Hip joint radiographs Acetabular Angle Central Edge Angle and Reimers Index Spinal radiographs Cobe Angle AP views Coronal Balance Sagital Balance Long standing views length of Femur and Tibia mLDFA mMPTA mLDTA JLCA the Baltimore numbers
All measurements will be taken by 4 senior orthopaedic surgeons after consensus conference for the technique
Intra observer reliability will be tested by repeating the same set of measurements on 2 different dates after all radiographs are randomly mixed and done at least 2 days apart High resolution single computer will be used for all measurements by all participating surgeons
The intra and inter observer reliability for the hip joint measurements will be calculate to compared between TraumaCad software wizard and the DICOM measurements tools
All measurements using TraumaCad software will be analyzed for intra and inter observer reliability using accepted statistical tools
The study will be supervised by the department of statistics of TAU for maximum statistical significance
1 Sailer J Scharitzer M Peloschek P Giurea A Imhof H Grampp S
Quantification of axial alignment of the lower extremity on conventional and digital total leg radiographs
Eur Radiol 2005 Jan 151170-3 Epub 2004 Aug 5
2 Hankemeier S Gosling T Richter M Hufner T Hochhausen C Krettek C
Computer-assisted analysis of lower limb geometry higher intraobserver reliability compared to conventional method
Comput Aided Surg 2006 Mar 11281-6
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None