Vertebral FractureNCT03369288
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
A study testing PET MRI in people with Vertebral Fracture and Cement Augmentation, run by University of Zurich at 1 site in Switzerland.
Trial summary
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertebral Fracture, Cement Augmentation
- What is being tested?
- PET MRI
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2017to 28 Nov 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 70 years
- Minimum 3-year follow-up
- Single-level vertebral kyphoplasty
- Index surgery at UniversitätsSpital Zürich
- MRI-scan during initial treatment
- Informed consent provided
Who cannot join
- Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
- Intraoperative intradiscal cement leakage
- Previous history of spinal surgery except on the cervical spine
- Metastatic disease with skeletal involvement
- Known chronic diseases of the bone metabolism other than osteoporosis
- Documented pregnancy (see also 6.3)
- Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Division of Trauma Surgery, University Hospital Zurich
Zurich, 8091
Georg Osterhoff, MD, +41 44 255 1111, georg.osterhoff@usz.ch
About this study
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
- Conditions
- Vertebral Fracture, Cement Augmentation
- Being tested
- PET MRI
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET MRIDiagnostic test
18F-fluoride PET-MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer Uptake
Perifokal tracer uptake at the cement-bone border
Measured: at least 3 years after kyphoplasty
Secondary outcomes (1)
Intravertebral Discs
Tracer uptake within the intravertebral disc and morphological changes
Measured: at least 3 years after kyphoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start5 Dec 2017
- Primary completion28 Jun 2019 (estimated)
- Study completion28 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective PET-MRI follow-up
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369288
- Sponsor's protocol ID
- 2017-01207
- Other IDs
- 2017
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
- ClinicalTrials.gov ID
- NCT03369288
- Acronym / sponsor ID
- 2017-01207
- Conditions
- Vertebral Fracture, Cement Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 28 Jun 2019 (estimated)
- Study completion
- 28 Nov 2019 (estimated)
- First posted
- 11 Dec 2017 (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.
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective PET-MRI follow-up
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 to 70 years
- Minimum 3-year follow-up
- Single-level vertebral kyphoplasty
- Index surgery at UniversitätsSpital Zürich
- MRI-scan during initial treatment
Key exclusion criteria (7 listed)
- Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
- Intraoperative intradiscal cement leakage
- Previous history of spinal surgery except on the cervical spine
- Metastatic disease with skeletal involvement
- Known chronic diseases of the bone metabolism other than osteoporosis
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 |
|---|---|---|
| PET MRI18F-fluoride PET-MRI | Diagnostic test | – |
Primary outcome
Tracer Uptake
Time frame: at least 3 years after kyphoplasty
Perifokal tracer uptake at the cement-bone border
1 secondary outcome
Intravertebral Discs
Time frame: at least 3 years after kyphoplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Vertebral Fracture
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruiting
StUdy oN Burst Fractures (SunBurst)
Thoracolumbar Burst Fracture
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET MRI in people with Vertebral Fracture and Cement Augmentation, run by University of Zurich 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 6 inclusion and 7 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 30 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Osterhoff, MD (0041 44 255 11 11, georg.osterhoff@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracer Uptake (time frame: at least 3 years after kyphoplasty). 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 30 Oct 2018.