Active, not recruiting
Not applicable
Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
Condition(s) studied
Vertebral Compression Fracture
Investigational drug(s) / intervention(s)
V-FlexV-Steady
V-Flex: Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
V-Steady: Bone Cement alone
Study summary
The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA bone cement is comparable to a PMMA bone cement alone (V-Steady).
Eligibility
Inclusion Criteria:
* Informed consent obtained before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the patient, i.e. standard of care);
* Symptomatic osteoporotic vertebral compression fracture without prior or not responding to medical treatment within 6 months;
* Maximum of 1 level of vertebral compression fractures eligible for treatment localized at level Th5 to L5 and verified by MRI or bone scan;
* Height reduction of the affected vertebra(e) with an anterior wall compression of not exceeding 60% compared to the nearest normal vertebral body determined by X-ray;
* Have pain correlating to the fractured levels requiring regular analgesic intake and/or causing substantial disability of daily life;
* Pain score ≥ 40 mm measured by VAS correlating to at least one of the fracture levels (scale 0 - 100 mm) at the screening visit;
* Oswestry Disability Index \> 20 (0 - 100 scale);
* SF-12PCS Index \< 80 (0 - 100 scale);
* Patient with a communicative ability to understand the procedure and participate in the study and comply with the follow up program.
Exclusion Criteria:
* Patients below 18 years;
* Any burst fracture;
* Unstable fractures defined by neurological deficit or interspinous process widening as evaluated by the Investigator, as well as kyphosis \> 30°, translation \> 4 mm;
* Established or suspected malignancy of the fractured vertebra. Hemangioma of the fractured vertebra;
* High energy trauma or clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis as suggested by progressive weakness;
* Have neurologic symptoms or deficits, or radiculopathy related to the fractured vertebrae;
* Patients with extremely high BMI, i.e. BMI ≥ 40;
* Previously treated with vertebroplasty or kyphoplasty;
* Patients with concomitant diseases which may be worsened by invasive treatment of the fracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm), as judged by the Investigator
* Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re- initiation of anticoagulants;
* Active systemic infection or local skin infection at the puncture site;
* Pregnancy or breast-feeding;
* Patients with known chemical dependency or drugs or with a medical history of drug abuse;
* Patients who are serving prison sentence;
* Have participated in another investigational study within 30 days prior to inclusion
* Pacemaker
* Previous or active radiotherapy affecting the spine
Primary outcome measure(s)
- New fractures — 1 year
To assess the effectiveness after administration of V-Flex compared to V-Steady as measured by reduction of new radiologically confirmed fractures.
- Location of fractures — 1 year
Assess the location of new fractures: adjacent or non-adjacent to the treated vertebral or re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
- Timing of fractures — 1 year
Assess the timing of adjacent, non-adjacent and re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
Trial sites (9)
| Facility | City | Region | Status |
| Beam Radiology |
Calgary |
Alberta |
|
| Mannheim University Hospital |
Mannheim |
Germany |
|
| Hospital in Mechernich |
Mechernich |
Germany |
|
| Lodz University Hospital |
Lodz |
Poland |
|
| Clínico San Carlos |
Madrid |
Spain |
|
| Fundación Jiménez Díaz |
Madrid |
Spain |
|
| Puerta de Hierro |
Madrid |
Spain |
|
| Hopsital Medina del Campo |
Medina del Campo |
Spain |
|
| University Hospital in Valladolid |
Valladolid |
Spain |
|