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HealthyNCT00782223

Assessment of Digital Radiograph Measurements of Hip,Spine and Lower Limbs

An observational study of Healthy, run by Tel-Aviv Sourasky Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Research Protocol Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population: using PACS integrated Computer Software (TraumaCad from OrthoCrat ™). Read more about this study

Who is it for?
Ages 2 months to 30 years
Conditions the study is for
Healthy
How many people
50 participants
Where
No sites listed yet
Study dates
Jul 2008to Dec 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Digital X-rays from PACS system

Who may be able to join

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

Who cannot join

  • inadequate X-rays

About this study

Official title: Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population: Using PACS Integrated Computer Software (TraumaCad From OrthoCrat)

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.

Read more

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. 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 Reimer's 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.
  3. 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; 15(1):170-3. Epub 2004 Aug 5.

  1. 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; 11(2):81-6

Conditions
Healthy
Keywords
hips, spine, lower limb, digital radiograph measurements, TraumaCad, digital software, Measurements of orthopaedic parameters on digital X-rays using particular software

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00782223
Study groupRoleWhat they receive
1Hip X-rays DDH
2Hip X-rays, CP
3Long standing lower Limb X-rays
4Scoliosis, AP X-rays
5Scoliosis Lateral X-rays

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00782223
Sponsor's protocol ID
0135-08-TLV
Status last verified
Oct 2008
First submitted
29 Oct 2008
Last updated
31 Oct 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Tel-Aviv Sourasky Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.

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