V-Steady + V-Flex for Spinal Fractures
(SOFTBONE Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inossia AB
Disqualifiers: Age below 18, High BMI, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you may need to follow routine practices for stopping and restarting them around the time of the procedure.
What data supports the effectiveness of the treatment V-Steady + V-Flex for spinal fractures?
Research suggests that using PMMA bone cement with reduced stiffness may be more suitable for reinforcing fragile bones, as it can lower the risk of fractures in nearby vertebrae. Additionally, combining PMMA with other materials like hydroxyapatite can improve bone healing and strength, which may support the effectiveness of treatments like V-Steady + V-Flex for spinal fractures.12345
Is the V-Steady + V-Flex treatment for spinal fractures safe?
The use of PMMA bone cement, a component of V-Steady + V-Flex, is generally considered safe, but there are some risks. Complications like vertebral collapse and fractures in nearby bones have been reported, especially if the cement doesn't mix well with the bone. Newer formulations aim to reduce these risks, but particle release during curing remains a concern.12367
How is the V-Steady + V-Flex treatment for spinal fractures different from other treatments?
The V-Steady + V-Flex treatment uses a modified PMMA bone cement with Inossia Cement Softener, which creates a more porous and less stiff material compared to traditional PMMA. This adaptation aims to reduce the risk of fractures in adjacent vertebrae by better matching the mechanical properties of natural bone.12589
Research Team
DN
David Noriega
Principal Investigator
University Hospital in Valladolid
Eligibility Criteria
This trial is for adults with painful osteoporotic vertebral compression fractures that haven't improved with medical treatment within the last 6 months. Participants must have a specific level of pain and disability, one treatable fracture between Th5 to L5 vertebrae, and be able to follow the study's procedures. Exclusions include cancer in the spine, severe obesity (BMI ≥ 40), prior similar treatments, certain coagulation disorders or infections, pregnancy, drug abuse history, recent participation in another study, pacemakers or radiotherapy affecting the spine.Inclusion Criteria
Informed consent obtained before any study-related activities
My back pain significantly affects my daily activities.
I need regular painkillers due to pain from a fracture affecting my daily life.
See 6 more
Exclusion Criteria
I have nerve symptoms or pain due to a broken vertebra.
I am under 18 years old.
I have a blood vessel growth in my fractured spine bone.
See 15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive vertebroplasty or kyphoplasty with PMMA alone (V-Steady) or PMMA mixed with Inossia™ Cement Softener (V-Flex)
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain, vertebral height, and quality of life
12 months
Multiple visits at 5 days, 3 months, and 12 months
Treatment Details
Interventions
- V-Flex (Bone Cement)
- V-Steady (Bone Cement)
Trial OverviewThe trial is testing two types of bone cement: V-Steady alone versus V-Flex which includes a softener additive. The goal is to see if adding Inossia™ Cement Softener makes any difference in safety and effectiveness when treating spinal compression fractures compared to using bone cement without it.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: V-FlexExperimental Treatment1 Intervention
Bone cement including Inossia Cement Softener
Group II: V-SteadyActive Control1 Intervention
Bone Cement alone
V-Flex is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as V-Flex for:
- Osteoporotic vertebral compression fractures
🇺🇸 Approved in United States as V-Flex for:
- Osteoporotic vertebral compression fractures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Inossia AB
Lead Sponsor
Trials
1
Patients Recruited
150+
Uppsala University
Collaborator
Trials
529
Patients Recruited
3,333,000+
EIT Health
Collaborator
Trials
14
Patients Recruited
10,300+
References
Properties of an injectable low modulus PMMA bone cement for osteoporotic bone. [2020]The use of polymethylmethacrylate (PMMA) cement to reinforce fragile or broken vertebral bodies (vertebroplasty) leads to extensive bone stiffening. Fractures in the adjacent vertebrae may be the consequence of this procedure. PMMA with a reduced Young's modulus may be more suitable. The goal of this study was to produce and characterize stiffness adapted PMMA bone cements. Porous PMMA bone cements were produced by combining PMMA with various volume fractions of an aqueous sodium hyaluronate solution. Porosity, Young's modulus, yield strength, polymerization temperature, setting time, viscosity, injectability, and monomer release of those porous cements were investigated. Samples presented pores with diameters in the range of 25-260 microm and porosity up to 56%. Young's modulus and yield strength decreased from 930 to 50 MPa and from 39 to 1.3 MPa between 0 and 56% porosity, respectively. The polymerization temperature decreased from 68 degrees C (0%, regular cement) to 41 degrees C for cement having 30% aqueous fraction. Setting time decreased from 1020 s (0%, regular cement) to 720 s for the 30% composition. Viscosity of the 30% composition (145 Pa s) was higher than the ones received from regular cement and the 45% composition (100-125 Pa s). The monomer release was in the range of 4-10 mg/mL for all porosities; showing no higher release for the porous materials. The generation of pores using an aqueous gel seems to be a promising method to make the PMMA cement more compliant and lower its mechanical properties to values close to those of cancellous bone.
Progressive collapse of PMMA-augmented vertebra: a report of three cases. [2008]Vertebroplasty using polymethylmethacrylate (PMMA) for augmentation is accepted as a safe and effective treatment for vertebral compression fracture. However, various complications related to PMMA vertebroplasty have recently been reported. We experienced three cases with progressive collapse of PMMA-augmented vertebra. Collapse progressed after augmentation in cases where PMMA conglomerated without contiguous bone interdigitation. A high viscosity of the PMMA preparation and vertebral body cavitory lesion may play a role in progressive vertebral collapse. To avoid this complication, bone cement should be injected sufficiently and permeate to contiguous bone to create strong support and anchorage.
Effect of Polymethylmethacrylate-Hydroxyapatite Composites on Callus Formation and Compressive Strength in Goat Vertebral Body. [2020]Introduction: Percutaneous vertebroplasty (PV) is one of the available treatments for vertebral compression fracture (VCF). Polymethylmethacrylate (PMMA) is the most common bone substitute used in the procedure, but it has several disadvantages. Bioceramic material, such as hydroxyapatite (HA), has better biological activity compared to PMMA. The aim of this study was to find an optimal biomaterial compound which offers the best mechanical and biological properties to be used in PV. Materials and Methods: This was an experimental study with goat (Capra aegagrus hircus) as an animal model. The animals' vertebral columns were injected with PMMA-HA compound. Animal samples were divided into four groups, and each group received a different proportion of PMMA:HA compound. The mechanical and biological effects of the compound on the bone were then analysed. The mechanical effect was assessed by measuring the vertebral body's compressive strength. Meanwhile, the biological effect was assessed by analysing the callus formation in the vertebral body. Results: The optimal callus formation and compressive strength was observed in the group receiving PMMA:HA with a 1:2 ratio. Conclusion: A mixture of PMMA and HA increases the quality of callus formation and the material's compressive strength. The optimum ratio of PMMA:HA in the compound is 1:2.
Does the cement stiffness affect fatigue fracture strength of vertebrae after cement augmentation in osteoporotic patients? [2022]Normal progression of osteoporosis or the rigid reinforcement of the fractured vertebral body with polymethyl methacrylate (PMMA) cement is being discussed as a cause for adjacent-level fractures after vertebroplasty. The purpose of this study was to investigate whether augmentation with low stiffness cement can decrease the risk of adjacent-level fractures in low-quality bone.
Response of fractured osteoporotic bone to polymethylacrylate after vertebroplasty: case report. [2019]Polymethylmethacrylate (PMMA) is the most commonly used bone cement for vertebroplasties to treat osteoporotic vertebral compression fractures (VCFs). Several studies have described the reaction of normal bone to PMMA, but it is still unclear how fractured osteoporotic bone responds to PMMA.
Two novel high performing composite PMMA-CaP cements for vertebroplasty: An ex vivo animal study. [2016]There is a growing body of the literature on new cement formulations that address the shortcomings of PMMA bone cements approved for use in vertebroplasty (VP) and balloon kyphoplasty (BKP). The present study is a contribution to these efforts by further characterization of two pre-mixed CaP filler-reinforced PMMA bone cements intended for VP; namely, PMMA-HA and PMMA-brushite cements. Each of these cements showed acceptable levels of various properties determined in porcine vertebral bodies. These properties included radiographic contrast, maximum exotherm temperature setting time, cement extravasation, stiffness change after fatigue loading, change of VB height after fracture following fatigue loading, and interdigitation. Each property value was comparable to or better than that for a PMMA bone cement approved for use in BKP. Thus, the results for the composite bone cements are promising.
Evaluation of the particle release of porous PMMA cements during curing. [2019]Poly(methyl methacrylate) (PMMA) remains the most common bone substitute material used for vertebroplasty. A possible downside with this material is that the Young's modulus of the cement is significantly higher than that of osteoporotic vertebral cancellous bone. In consequence, an increased fracture risk has been demonstrated for the adjacent vertebral bodies after reinforcement. A solution could be to prepare porous bone cements with a lower bulk modulus as suggested by De Wijn (De Wijn JR. Poly(methyl methacrylate)-aqueous phase blends: in situ curing porous materials. J Biomed Mater Res 1976;10:625-35). The potential of such porous PMMA cements for application in vertebroplasty has been shown in the literature. The present study was performed to study the release of particles, e.g. powder particles such as barium sulfate or hydroxyapatite, from PMMA cements containing an aqueous phase. The aqueous phase was introduced to act as a pore-forming phase to soften the cement and is thought to be released when applied in vivo. Cement particle release is not suitable for the application as they may cause adverse reactions such as embolism. The purpose of the present study was to investigate the amount of the particles released in relation to various aqueous solutions and different preparation methods. As a result of the work presented here, a method was found to reduce the particle release by delayed admixing of the aqueous phase to the partially polymerized PMMA/MMA mixture. This method leads to a reduction in particle release of more than 50%, e.g. reduced from 1.3 to 0.6g particles per 4ml of cement. Despite these improvements, particle release could not be reduced to a suitable level comparable to regular vertebroplasty cement. Therefore, the practicability of the initially promising invention of porous PMMA, in order to make regular PMMA cement more compliant with cancellous bone remains an unsolved issue.
Intravertebral clefts in osteoporotic compression fractures of the spine: incidence, characteristics, and therapeutic efficacy. [2022]To determine the pathogenesis and characteristics and to assess the long-term effectiveness of polymethylmethacry late (PMMA) vertebroplasty treatment in patients with intravertebral cleft (IVC) in osteoporotic compression fractures.
The effects of bone and pore volume fraction on the mechanical properties of PMMA/bone biopsies extracted from augmented vertebrae. [2011]Vertebroplasty forms a porous PMMA/bone composite which was shown to be weaker and less stiff than pure PMMA. It is not known what determines the mechanical properties of such composites in detail. This study investigated the effects of bone volume fraction (BV/TV), cement porosity (PV/(TV-BV), PV…pore volume) and cement stiffness. Nine human vertebral bodies were augmented with either standard or low-modulus PMMA cement and scanned with a HR-pQCT system before and after augmentation. Fourteen cylindrical PMMA/bone biopsies were extracted from the augmented region, scanned with a micro-CT system and tested in compression until failure. Micro-finite element (FE) models of the complete biopsies, of the trabecular bone alone as well as of the porous cement alone were generated from CT images to gain more insight into the role of bone and pores. PV/(TV-BV) and experimental moduli of standard/low-modulus cement (R(2)=0.91/0.98) as well as PV/(TV-BV) and yield stresses (R(2)=0.92/0.83) were highly correlated. No correlation between BV/TV (ranging from 0.057 to 0.138) and elastic moduli was observed (R(2)