Underdevelopment; Congenital Malformation, Lower LimbNCT02332018
Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol
An observational study of Underdevelopment; Congenital Malformation, Lower Limb and Scoliosis, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Underdevelopment; Congenital Malformation, Lower Limb, Scoliosis
- What is being tested?
- Biplanar x-ray images
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2014to 6 Jan 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients referred for assessment of spine or lower limb with biplanar x-ray-scanner
Who may be able to join
- Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Radiology Department, Balgrist University Clinic
Zurich, Canton of Zurich, 8008
About this study
Official title: Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol
Read the detailed description
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol
Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol
- Being tested
- Biplanar x-ray images
- Medical subject headings
- Congenital Abnormalities, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biplanar x-ray imagesRadiation
biplanar x-ray images with microdose and low-dose protocol
| Study group | Role | What they receive |
|---|---|---|
| Limb Torsion | adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images Receives: Radiation: Biplanar x-ray images | |
| Limb Length and Axis | adult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images Receives: Radiation: Biplanar x-ray images | |
| Spine | adult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images Receives: Radiation: Biplanar x-ray images |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJul 2014
- Primary completion6 Jan 2016
- Study completion6 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underdevelopment; Congenital Malformation, Lower LimbStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Rosskopf, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332018
- Sponsor's protocol ID
- KEK-ZH-Nr.: 2014-0405
- Status last verified
- Feb 2017
- First submitted
- 5 Jan 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol
- ClinicalTrials.gov ID
- NCT02332018
- Acronym / sponsor ID
- KEK-ZH-Nr.: 2014-0405
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 6 Jan 2016 (actual)
- Study completion
- 6 Jan 2016 (actual)
- First posted
- 6 Jan 2015 (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.
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol
Detailed description
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol
Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Limb Torsion | – | Radiation: Biplanar x-ray imagesadult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images |
| Limb Length and Axis | – | Radiation: Biplanar x-ray imagesadult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images |
| Spine | – | Radiation: Biplanar x-ray imagesadult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for assessment of spine or lower limb with biplanar x-ray-scanner
Key inclusion criteria (1 listed)
- Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biplanar x-ray imagesbiplanar x-ray images with microdose and low-dose protocol | Radiation | Limb Length and Axis, Limb Torsion, Spine |
Primary outcome
2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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.
Andrea Rosskopf principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Underdevelopment; Congenital Malformation, Lower Limb and Scoliosis, run by Balgrist University Hospital at 1 site in Switzerland.
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 0 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: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters (time frame: 12 month). It is what the study was designed to measure, not a finding.
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 20 Feb 2017.