New softer cement could reduce repeat spine fractures
NCT ID NCT05676320
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two bone cements used to treat painful spinal fractures caused by osteoporosis. One cement includes a softener (V-Flex) to make it less rigid, while the other is standard cement (V-Steady). The goal is to see if the softer cement reduces the chance of new fractures nearby and improves pain and function. About 200 participants with one recent fracture will be followed for two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone cement with cement softener (Inossia® Cement Softener)
- What this could lead to
- If it works, this could provide a safer, more effective option for treating spinal fractures, potentially reducing the risk of new fractures nearby.
- What could go wrong
- This is a mid-stage trial with 203 participants, so results may not apply to everyone. Adding a softener might not improve outcomes and could introduce unknown risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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203 people
The number who actually took part.
- Started
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Mar 2021
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beam Radiology
Calgary, Alberta, Canada
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Clínico San Carlos
Madrid, Spain
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Fundación Jiménez Díaz
Madrid, Spain
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Hopsital Medina del Campo
Medina del Campo, Spain
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Hospital in Mechernich
Mechernich, Germany
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Lodz University Hospital
Lodz, Poland
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Mannheim University Hospital
Mannheim, Germany
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Puerta de Hierro
Madrid, Spain
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University Hospital in Valladolid
Valladolid, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Spine fracture fix: new device aims to ease back pain
- New bone graft aims to ease pain from spine fractures
- Spine fracture pain: which procedure works best?
- Spinal fracture patients: did integrative korean medicine help? new study looks back at real-world results
- New spinal device shows promise in early fracture study