HealthyNCT00782223
Assessment of Digital Radiograph Measurements of Hip,Spine and Lower Limbs
An observational study of Healthy, run by Tel-Aviv Sourasky Medical Center.
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
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population: Using PACS Integrated Computer Software (TraumaCad From OrthoCrat)
- ClinicalTrials.gov ID
- NCT00782223
- Acronym / sponsor ID
- 0135-08-TLV
- Conditions
- Healthy
- Keywords
- hips, spine, lower limb, digital radiograph measurements, TraumaCad, digital software, Measurements of orthopaedic parameters on digital X-rays using particular software
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (estimated)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Digital X-rays from PACS system
Key inclusion criteria (1 listed)
- hip, long leg \& spine digital X-rays
Key exclusion criteria (1 listed)
- inadequate X-rays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.