A Phase 4 interventional study of Vertebral Body Stenting (VBS) and Balloon Kyphoplasty in Vertebral Body Fractures, sponsored by Synthes GmbH. Completed at 5 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by Synthes GmbH (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
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.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 100 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted before Synthes GmbH became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All target VCFs are between Th5 and L5
All target VCFs to be treated show either:
Exclusion Criteria:
Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Vertebral Body Stenting (VBS)
Procedure: Balloon Kyphoplasty
Vertebral Augmentation with a Stent
Vertebral Augmentation with a Balloon (device not specified)
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 2 years
Disability using the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), version 2.1 will be used.
Time frame: 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.
Time frame: 2 years
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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