Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
NCT ID: NCT05676320
Last Updated: 2025-12-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
203 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-11
Study Completion Date
2026-05-31
Brief Summary
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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).
Detailed Description
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The clinical investigation is a prospective, single-blind, controlled multi-center study of vertebral compression fractures treated by vertebroplasty or kyphoplasty with PMMA alone (V-Steady) or PMMA mixed with Inossia® Cement Softener (V-Flex).
The overall purpose of conducting this study is to confirm the safety and efficacy of Inossia® Cement Softener mixed with PMMA for augmentation of osteoporotic vertebral compression fractures and to verify that the V-Flex is, at least, comparable (non-inferior) to the PMMA products used today.
All eligible patients will be invited to participate in the study. A total of 150 patients will be enrolled in the study.
The overall purpose of conducting this study is to confirm the safety and efficacy of Inossia® Cement Softener mixed with PMMA for augmentation of osteoporotic vertebral compression fractures and to verify that the V-Flex is, at least, comparable (non-inferior) to the PMMA products used today.
All eligible patients will be invited to participate in the study. A total of 150 patients will be enrolled in the study.
Conditions
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Vertebral Compression Fracture
Keywords
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vertebral compression fracture
bone cement
vertebroplasty
kyphoplasty
osteoporosis
softener
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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V-Flex
Bone cement including Inossia® Cement Softener
Group Type
EXPERIMENTAL
V-Flex
Intervention Type
DEVICE
Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
V-Steady
Bone Cement alone
Group Type
ACTIVE_COMPARATOR
V-Steady
Intervention Type
DEVICE
Bone Cement alone
Interventions
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V-Flex
Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
Intervention Type
DEVICE
V-Steady
Bone Cement alone
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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EIT Health
OTHER
Sponsor Role
collaborator
Uppsala University
OTHER
Sponsor Role
collaborator
Inossia AB
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Noriega
Role: PRINCIPAL_INVESTIGATOR
University Hospital in Valladolid
Locations
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Beam Radiology
Calgary, Alberta, Canada
Site Status
Mannheim University Hospital
Mannheim, , Germany
Site Status
Hospital in Mechernich
Mechernich, , Germany
Site Status
Lodz University Hospital
Lodz, , Poland
Site Status
Clínico San Carlos
Madrid, , Spain
Site Status
Puerta de Hierro
Madrid, , Spain
Site Status
University Hospital in Valladolid
Valladolid, , Spain
Site Status
Countries
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Canada
Germany
Poland
Spain
References
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Other Identifiers
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SOFTBONE 1512:1
Identifier Type: -
Identifier Source: org_study_id