Vertebral Body FracturesPhase 4NCT01847898
Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
A Phase 4 study testing Vertebral Body Stenting (VBS) and Balloon Kyphoplasty in people with Vertebral Body Fractures, run by Synthes GmbH at 5 sites in 2 countries.
Trial summary
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Body Fractures
- What is being tested?
- Vertebral Body Stenting (VBS) and Balloon Kyphoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Sep 2009to 31 Dec 2015
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50
- 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
- Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
- All target VCFs are between Th5 and L5
- All target VCFs to be treated show either:
- Height change: An acute (< 6 month) change in VB height (>15% height loss) with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of 1 or more grades by the Genant criteria, OR
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- Positive MRI or bone scan: VB shows hyperintense signal on MRI-T2 or STIR sequence or target VB is positive on radionuclide bone scan
- Back pain correlating with the location of at least one VCF
- Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
- No major surgery to the spine planned for at least 1 month following enrollment
- Pre-treatment back pain by numerical rating scale (NRS) score >= 4 (0-10 scale)
- Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
- Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures
Who cannot join
- VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
- Fracture due to high-energy trauma
- Suspected OR proven cancer inside index vertebral body.
- Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
- Any painful VCF with fracture age > 6 months
- Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
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- Any objective evidence of neurologic compromise at baseline
- Previous balloon kyphoplasty or vertebroplasty for any VCF
- Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted VCFs
- Significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
- Patients requiring the use of high-dose steroid (>= 100mg prednisone or 20 mg dexamethasone per day), IV pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
- Patients who may require allogeneic bone marrow transplantation during the course of the study
- Spinal cord compression or canal compromise requiring decompression
- Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors of vertebral levels not intended for kyphoplasty may be enrolled.
- MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
- Spinal instability as indicated by neurologic deficit, kyphosis >30°, compression >50%, translation > 4 mm, interspinous-process widening.
- Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:
- Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
- Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty or vertebroplasty. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used.
- Any evidence of VB or systemic infection
- Pregnant or child-bearing potential
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Universitätsklinikum Schleswig-Holstein
Kiel
Universitätsklinikum
Münster
Universitätsklinik und Poliklinik für Chirurgie
Rostock
About this study
Official title: Study to Evaluate the Clinical Performance of the VBS System for the Treatment of Osteoporotic Vertebral Fractures in a Multicenter, Randomized, Controlled Setting
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine.
The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.
- Conditions
- Vertebral Body Fractures
- Being tested
- Vertebral Body Stenting (VBS), Balloon Kyphoplasty
- Keywords
- Osteoporosis, Vertebral Body, Compression Fracture, Kyphoplasty
- Medical subject headings
- Osteoporosis, Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Body Stenting (VBS)Procedure or surgery
Vertebral Augmentation with a Stent
Balloon KyphoplastyProcedure or surgery
Vertebral Augmentation with a Balloon (device not specified)
| Study group | Role | What they receive |
|---|---|---|
| Vertebral Body Stenting (VBS) | Experimental | Not described Receives: Procedure: Vertebral Body Stenting (VBS) |
| Balloon Kyphoplasty | Experimental | Not described Receives: Procedure: Balloon Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase and maintenance of the vertebral body height
The anterior edge, mid height and posterior edge of the index vertebral body are measured pre-operatively standing, after prone intraoperative positioning on the table (dynamic fracture mobility), intra-operatively following balloon dilation (height restoration), after balloon deflation and removal, after cement deposition, and finally postoperative standing. Anterior, middle and posterior height measurements will be made at each time-point during the study to measure maintenance of vertebral body height over time. The ratio between anterior and mid or posterior edge height (Beck-index) is calculated to avoid the problem of image calibration. In addition, the relative height fractions in comparison to the nearest healthy vertebral body (referent level) are calculated. Finally, local and regional sagittal angles and overall lumbar lordosis or thoracic kyphosis, respectively, are assessed for measurement of improvement of alignment.
Measured: 12 months
Visual analog scale (VAS) for back pain
Pain assessment by the patients using the VAS back pain from 0 to 10. In this scale 0 means "no pain" and 10 is the "worst pain imaginable". A pre- to postoperative difference of at least 2 observed during the course of the therapy is regarded as clinically relevant.
Measured: 12 months
Adverse events
- Any re-operations, revisions, and removals or supplemental fixation at the index level(s) is considered a study failure.
- Any intra-operative system malfunction, misplacement of the balloon or stent, balloon or stent fracture, or failure of the balloon or stent to fully deploy is considered a study failure.
Measured: 12 months
Secondary outcomes (8)
Radiographic evaluations
Evaluation of osteolysis surrounding the VBS System and/or cement; Evaluation of adjacent level arthritis; Evaluation of bridging trabecular bone at intradiscal spaces adjacent to the treated level(s); Assessment of segmental kyphosis/lordosis at the treated and adjacent level(s) Evaluation of all vertebral body fractures directly above and below the treated level(s
Measured: 2 years
Global assessment by the patient using the VAS
Patients globally assess their overall satisfaction with the treatment using the VAS, where 0 = totally dissatisfied and 10 = totally satisfied. A six-level question comparing the current situation to the preoperative state of health is also used.
Measured: 2 years
VAS leg pain
VAS leg pain from 0 to 10. In this scale 0 means "no pain" and 10 is the "worst pain imaginable".
Measured: 2 years
Analgesic usage
Analgesic consumption is documented in the categories - none, Paracetamol (Acetaminophen), Nonsteroidal anti-inflammatory drugs (NSAID), Metamizole, mild opiates and strong opiates at baseline and each follow-up office visit. This information is obtained with the help of medical staff or the patient's family and relatives.
Measured: 2 years
Neurological assessment of root tension signs, muscle strength, sensory deficit and reflexes
Assessment of root tension signs (yes/no), muscle strength (normal/decreased), sensory deficit (yes/no) and reflexes (normal/decreased/increased) will be conducted at baseline and each follow-up visit
Measured: 2 years
Symptoms associated with position/direction of cement extrusion
Symptoms associated with position/direction of cement extrusion: epidural, pulmonary, intradiscal, large vessels, foraminal, paraspinal soft tissue, paravertebral vessels, other.
Measured: 2 years
Disability using the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), version 2.1 will be used.
Measured: 2 years
Quality of Life Evaluation using the EuroQol, general quality of life questionnaire (EQ-5D)
The EQ-5D (EuroQol, general quality of life questionnaire) will be used.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study start1 Sep 2009
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Body FracturesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul F. Heini, Prof. Dr. med., Principal investigator, Klinik Sonnenhof, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847898
- Sponsor's protocol ID
- STU-SPI-S-06-134-01
- Other IDs
- STU-SPI-S-06-134-01
- Status last verified
- Mar 2017
- First submitted
- 27 Aug 2009
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Clinical Performance of the VBS System for the Treatment of Osteoporotic Vertebral Fractures in a Multicenter, Randomized, Controlled Setting
- ClinicalTrials.gov ID
- NCT01847898
- Acronym / sponsor ID
- STU-SPI-S-06-134-01
- Conditions
- Vertebral Body Fractures
- Keywords
- Osteoporosis, Vertebral Body, Compression Fracture, Kyphoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 7 May 2013 (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.
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine.
The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebral Body Stenting (VBS) | Experimental | Procedure: Vertebral Body Stenting (VBS) |
| Balloon Kyphoplasty | Experimental | Procedure: Balloon Kyphoplasty |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 50
- 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
- Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
- All target VCFs are between Th5 and L5
- Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
Key exclusion criteria (21 listed)
- VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
- Fracture due to high-energy trauma
- Suspected OR proven cancer inside index vertebral body.
- Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
- Any painful VCF with fracture age > 6 months
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 |
|---|---|---|
| Vertebral Body Stenting (VBS)Vertebral Augmentation with a Stent | Procedure or surgery | Vertebral Body Stenting (VBS) |
| Balloon KyphoplastyVertebral Augmentation with a Balloon (device not specified) | Procedure or surgery | Balloon Kyphoplasty |
Primary outcome
Increase and maintenance of the vertebral body height
Time frame: 12 months
The anterior edge, mid height and posterior edge of the index vertebral body are measured pre-operatively standing, after prone intraoperative positioning on the table (dynamic fracture mobility), intra-operatively following balloon dilation (height restoration), after balloon deflation and removal, after cement deposition, and finally postoperative standing. Anterior, middle and posterior height measurements will be made at each time-point during the study to measure maintenance of vertebral body height over time. The ratio between anterior and mid or posterior edge height (Beck-index) is calculated to avoid the problem of image calibration. In addition, the relative height fractions in comparison to the nearest healthy vertebral body (referent level) are calculated. Finally, local and regional sagittal angles and overall lumbar lordosis or thoracic kyphosis, respectively, are assessed for measurement of improvement of alignment.
Visual analog scale (VAS) for back pain
Time frame: 12 months
Pain assessment by the patients using the VAS back pain from 0 to 10. In this scale 0 means "no pain" and 10 is the "worst pain imaginable". A pre- to postoperative difference of at least 2 observed during the course of the therapy is regarded as clinically relevant.
Adverse events
Time frame: 12 months
* Any re-operations, revisions, and removals or supplemental fixation at the index level(s) is considered a study failure. * Any intra-operative system malfunction, misplacement of the balloon or stent, balloon or stent fracture, or failure of the balloon or stent to fully deploy is considered a study failure.
8 secondary outcomes
Radiographic evaluations
Time frame: 2 years
Global assessment by the patient using the VAS
Time frame: 2 years
VAS leg pain
Time frame: 2 years
Analgesic usage
Time frame: 2 years
Neurological assessment of root tension signs, muscle strength, sensory deficit and reflexes
Time frame: 2 years
Symptoms associated with position/direction of cement extrusion
Time frame: 2 years
Disability using the Oswestry Disability Index (ODI)
Time frame: 2 years
Quality of Life Evaluation using the EuroQol, general quality of life questionnaire (EQ-5D)
Time frame: 2 years
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 14 Mar 2017.
Related trials for Vertebral Body Fractures
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
Active, not recruiting
Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment
Osteoporotic Vertebral Compression Fractures
Active, not recruitingObservational study
Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
Osteoporosis, Hyperkyphosis
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.
Paul F. Heini, Prof. Dr. med. principal investigator
Klinik Sonnenhof, Bern, Switzerland
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vertebral Body Stenting (VBS) and Balloon Kyphoplasty in people with Vertebral Body Fractures, run by Synthes GmbH at 5 sites in 2 countries.
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 13 inclusion and 21 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Increase and maintenance of the vertebral body height (time frame: 12 months). The study lists 3 primary outcomes in all. 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 14 Mar 2017.