Spinal DiseaseNCT04954963
CT Mar Technology and MR Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation
An observational study of Spinal Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
1. Objective to compare the effect of single energy imaging and mar technology in reducing artifacts of knee and hip replacement, and to explore the appropriate keV range of Mar technology in removing metal artifacts.,2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Reduce metal artifacts examination
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From December 2019 to October 2020, patients who were reexamined after spinal internal fixation or knee and hip replacement in Peking University Third Hospital.
Who may be able to join
- Patients after spinal internal fixation or knee or hip replacement
Who cannot join
- Patients with poor image quality caused by their own factors such as patients' movement can not meet the diagnostic requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective to Explore the Clinical Application Value of Spectral CT Mar Technology and Magnetic Resonance Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation
- Objective to compare the effect of single energy imaging and mar technology in reducing artifacts of knee and hip replacement, and to explore the appropriate keV range of Mar technology in removing metal artifacts.,2. Objective to compare the effects of different MRI sequences (mavric / semac, stir, ideal, FSE) in removing artifacts of spinal internal fixation, knee and hip replacement.
Read the detailed description
Conventional spiral CT [4] examination will form black-and-white stripe artifacts around the metal implant, making the display of adjacent important structures unclear. In routine MRI examination [5], metal will interfere with the uniformity of local magnetic field, resulting in signal loss, and the artifacts will seriously affect the observation of bone and its surrounding structures.
The purpose of this study was to comprehensively evaluate the effect of Mar technology on reducing metal artifacts after internal fixation and joint replacement, and then to explore the appropriate keV range of Mar technology to reduce metal artifacts. We also aim to compare the reduction effect of different sequences of MRI on internal fixation artifacts after internal fixation and joint replacement, and to explore the sequence suitable for clinical diagnosis and treatment.
- Conditions
- Spinal Disease
- Being tested
- Reduce metal artifacts examination
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduce metal artifacts examinationDiagnostic test
patients undergo reduce metal artifacts examination
| Study group | Role | What they receive |
|---|---|---|
| conventional examination | patients undergo conventional examination | |
| Reduce metal artifacts examination | patients undergo reduce metal artifacts examination Receives: Diagnostic Test: Reduce metal artifacts examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artifact index
AI in region of interest
Measured: 2020.10.15-2020.10.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2019
- Primary completion1 Dec 2019
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954963
- Sponsor's protocol ID
- M2019317
- Status last verified
- Dec 2019
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective to Explore the Clinical Application Value of Spectral CT Mar Technology and Magnetic Resonance Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation
- ClinicalTrials.gov ID
- NCT04954963
- Acronym / sponsor ID
- M2019317
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 8 Jul 2021 (actual)
- 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.
- Objective to compare the effect of single energy imaging and mar technology in reducing artifacts of knee and hip replacement, and to explore the appropriate keV range of Mar technology in removing metal artifacts.,2. Objective to compare the effects of different MRI sequences (mavric / semac, stir, ideal, FSE) in removing artifacts of spinal internal fixation, knee and hip replacement.
Detailed description
Conventional spiral CT [4] examination will form black-and-white stripe artifacts around the metal implant, making the display of adjacent important structures unclear. In routine MRI examination [5], metal will interfere with the uniformity of local magnetic field, resulting in signal loss, and the artifacts will seriously affect the observation of bone and its surrounding structures.
The purpose of this study was to comprehensively evaluate the effect of Mar technology on reducing metal artifacts after internal fixation and joint replacement, and then to explore the appropriate keV range of Mar technology to reduce metal artifacts. We also aim to compare the reduction effect of different sequences of MRI on internal fixation artifacts after internal fixation and joint replacement, and to explore the sequence suitable for clinical diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional examination | – | –patients undergo conventional examination |
| Reduce metal artifacts examination | – | Diagnostic Test: Reduce metal artifacts examinationpatients undergo reduce metal artifacts examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From December 2019 to October 2020, patients who were reexamined after spinal internal fixation or knee and hip replacement in Peking University Third Hospital.
Key inclusion criteria (1 listed)
- Patients after spinal internal fixation or knee or hip replacement
Key exclusion criteria (1 listed)
- Patients with poor image quality caused by their own factors such as patients' movement can not meet the diagnostic requirements
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 |
|---|---|---|
| Reduce metal artifacts examinationpatients undergo reduce metal artifacts examination | Diagnostic test | Reduce metal artifacts examination |
Primary outcome
Artifact index
Time frame: 2020.10.15-2020.10.30
AI in region of interest
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 8 Jul 2021.
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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.
Huishu Yuan study chair
Peking University Third 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 Spinal Disease, run by Peking University Third Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 8 Jul 2021. 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 China. 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?
Artifact index (time frame: 2020.10.15-2020.10.30). 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 8 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.