NCT00782223

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 software's. 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. 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. 2.To assess intra and inter observer reliability of the TraumaCad software for different pediatric orthopaedics conditions.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

October 29, 2008

Last Update Submit

October 29, 2008

Conditions

Keywords

hips, spine, lower limb, digital radiograph measurements, TraumaCad, digital softwareMeasurements of orthopaedic parameters on digital X-rays using particular software

Study Arms (5)

1

Hip X-rays DDH

2

Hip X-rays, CP

3

Long standing lower Limb X-rays

4

Scoliosis, AP X-rays

5

Scoliosis Lateral X-rays

Eligibility Criteria

Age2 Months - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Digital X-rays from PACS system

You may qualify if:

  • hip, long leg \& spine digital X-rays

You may not qualify if:

  • inadequate X-rays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Last Updated

October 31, 2008

Record last verified: 2008-10