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Active, not recruiting Not applicable

Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures

NCT05676320 · tracked via the Priya Life Science Poland tracker
Sponsor
Inossia AB
Phase
Not applicable
Started
2021-03-11
Last updated
2026-04-08

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05676320 on ClinicalTrials.gov ↗ ← All trials in Poland