V-Steady + V-Flex for Spinal Fractures

(SOFTBONE Trial)

Recruiting at 7 trial locations

Overseen By Anna Gibernau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inossia AB

Disqualifiers: Age below 18, High BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 week

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, V-Flex and V-Steady, for individuals with back pain from specific spinal fractures due to osteoporosis. V-Flex includes a cement softener, while V-Steady uses regular bone cement. Researchers aim to determine if V-Flex is as safe and effective as V-Steady. Individuals with vertebral compression fractures for up to six months, causing significant pain and daily disability, might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options for back pain.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that V-Flex, which includes the Inossia Cement Softener, might be safer than regular bone cement. One study suggested that V-Flex could reduce the risk of new spinal fractures by 75%, potentially leading to fewer additional fractures for patients. V-Flex employs a special method to soften the cement, allowing it to better fit bones weakened or made brittle by osteoporosis.

In contrast, V-Steady is the regular bone cement without the softener and is already used in medical treatments, indicating it is generally well tolerated. No specific evidence has shown safety issues with V-Steady.

Both treatments are under study to assess their safety and effectiveness in treating spinal fractures. The researchers aim to determine if the softer cement in V-Flex is as safe and effective as the traditional V-Steady cement. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about V-Flex and V-Steady because these treatments offer innovative approaches to managing spinal fractures. Unlike traditional bone cements, V-Flex incorporates Inossia Cement Softener, which may enhance the flexibility and adaptability of the cement, potentially improving patient outcomes. V-Steady, serving as an active comparator, provides a baseline to evaluate the benefits of adding the softener. The combination of these treatments could lead to more effective stabilization of spinal fractures, offering new hope to patients needing advanced care.

What evidence suggests that this trial's treatments could be effective for spinal fractures?

Research has shown that V-Flex, which uses a softer type of cement, might significantly reduce the risk of new spine fractures in patients with osteoporosis-related spinal fractures. Some studies suggest a 75% reduction in these fractures when using this softer cement compared to traditional types. This softer cement addresses issues commonly associated with bone cement procedures. In this trial, participants will receive either V-Flex or V-Steady, the standard bone cement used in these treatments. Both options are under study for their effectiveness in treating spinal fractures, with V-Flex showing promising early results due to its new formula. ^{2 3 4 5 6}

Who Is on the Research Team?

David Noriega

Principal Investigator

University Hospital in Valladolid

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• V-Flex
• V-Steady

Trial Overview The 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.

How Is the Trial Designed?

Group I: V-Flex Experimental Treatment 1 Intervention

Bone cement including Inossia Cement Softener

Group II: V-Steady Active Control 1 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

Who Is Running the Clinical Trial?

Inossia AB

Lead Sponsor

Trials

1

Recruited

150+

Uppsala University

Collaborator

Trials

529

Recruited

3,333,000+

EIT Health

Collaborator

Trials

14

Recruited

10,300+

Published Research Related to This Trial

In an experimental study using goats, a compound of PMMA and hydroxyapatite (HA) was tested for its effectiveness in treating vertebral compression fractures, showing improved mechanical and biological properties compared to PMMA alone.

The best results for callus formation and vertebral compressive strength were achieved with a PMMA:HA ratio of 1:2, indicating this mixture could enhance recovery in vertebral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Polymethylmethacrylate-Hydroxyapatite Composites on Callus Formation and Compressive Strength in Goat Vertebral Body. Komang-Agung, IS., Hydravianto, L., Sindrawati, O., et al.[2020]

The study evaluated two new types of bone cements, PMMA-HA and PMMA-brushite, which showed promising properties for use in vertebroplasty, including good radiographic contrast and acceptable setting times.

These new cements demonstrated comparable or improved performance over traditional PMMA bone cements in terms of stiffness, cement extravasation, and maintaining vertebral body height after loading, suggesting they could enhance the safety and efficacy of vertebral fracture treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two novel high performing composite PMMA-CaP cements for vertebroplasty: An ex vivo animal study. Aghyarian, S., Hu, X., Lieberman, IH., et al.[2016]

Vertebroplasty using polymethylmethacrylate (PMMA) is generally considered a safe and effective treatment for vertebral compression fractures, but complications can occur, including progressive collapse of the augmented vertebra.

In three cases, the collapse was linked to insufficient interdigitation of PMMA with surrounding bone, suggesting that proper injection techniques and ensuring the cement permeates contiguous bone are crucial for preventing this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive collapse of PMMA-augmented vertebra: a report of three cases. Shin, DA., Kim, KN., Shin, HC., et al.[2008]

The study developed a new type of porous PMMA bone cement that reduces stiffness and yield strength, making it more similar to natural bone, which could help prevent fractures in adjacent vertebrae after vertebroplasty.

By incorporating sodium hyaluronate, the new cement showed a significant decrease in Young's modulus from 930 MPa to 50 MPa, suggesting it may provide better support and flexibility for fragile vertebral bodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Properties of an injectable low modulus PMMA bone cement for osteoporotic bone. Boger, A., Bohner, M., Heini, P., et al.[2020]

The mechanical properties of vertebroplasty composites are primarily influenced by the porosity of the PMMA cement and its material properties, rather than the volume of bone present, as shown in a study involving nine human vertebral bodies.

Micro-finite element models indicated that the load-bearing capacity of the biopsies was mainly supported by the porous PMMA cement, suggesting that the bone tissue's contribution to mechanical strength was minimal in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of bone and pore volume fraction on the mechanical properties of PMMA/bone biopsies extracted from augmented vertebrae. Kinzl, M., Boger, A., Zysset, PK., et al.[2011]

Using a modified PMMA cement with lower stiffness can significantly reduce the risk of adjacent-level fractures after vertebroplasty in osteoporotic bones, as shown by a 51% decrease in cement stiffness and improved fatigue fracture force in testing.

The study involved 18 female osteoporotic lumbar specimens and demonstrated that the modified PMMA group had a higher fatigue fracture force compared to standard PMMA, suggesting that tailoring cement properties could enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the cement stiffness affect fatigue fracture strength of vertebrae after cement augmentation in osteoporotic patients? Kolb, JP., Kueny, RA., Püschel, K., et al.[2022]

In a study of 388 patients treated with vertebroplasty for osteoporotic compression fractures, those with intravertebral cleft (IVC) showed initial improvement in vertebral height and pain relief, but these benefits diminished over a 2-year follow-up period.

Patients with IVC experienced a greater recurrence of compression and kyphosis compared to those without IVC, indicating that while vertebroplasty is effective initially, long-term outcomes are less favorable, necessitating close monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravertebral clefts in osteoporotic compression fractures of the spine: incidence, characteristics, and therapeutic efficacy. Fang, X., Yu, F., Fu, S., et al.[2022]

A case study of a 69-year-old woman showed that fractured osteoporotic bone can still heal after being treated with PMMA during vertebroplasty, indicating a positive response to this treatment.

Histological analysis revealed viable bone and granulation tissue around the PMMA, suggesting that while some necrotic bone was present, the overall healing process was not significantly hindered by the cement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of fractured osteoporotic bone to polymethylacrylate after vertebroplasty: case report. Kim, CW., Minocha, J., Wahl, CE., et al.[2019]

The study found that while porous PMMA cements could potentially reduce the risk of adjacent vertebral fractures due to their lower bulk modulus, they still release harmful particles that could cause adverse reactions, such as embolism.

A new method of delaying the addition of the aqueous phase to the PMMA mixture successfully reduced particle release by over 50%, but the levels remained too high for safe use compared to standard vertebroplasty cement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the particle release of porous PMMA cements during curing. Beck, S., Boger, A.[2019]

Citations

1. cordis.europa.eu cordis.europa.eu/project/id/190175074/reporting

Inossia Cement Softener - a new and unique additive to bone ... By replacing standard bone cements with softer cements enabled by ICS, we estimate to reduce the risk of new unnecessary vertebral fractures by 75% (from 20% ...

2. inossia.com inossia.com/important-milestone-reached-150-patients-enrolled/

Important milestone reached - 150 patients enrolled The study's goal is to follow these patients for one year and show a reduced number of new vertebral fractures when using our new type of soft ...

3. clinicaltrial.be clinicaltrial.be/nl/details/187942?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=1&per_page=100

Investigating Bone Cement With or Without Inossia ... 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 ...

4. trialx.com trialx.com/clinical-trials/listings/238189/investigating-bone-cement-with-or-without-inossiatm-cement-softener-for-vertebral-compression-fractures/

Investigating Bone Cement With or Without Inossia ... The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40714190/

Low modulus PMMA-based bone cement for the reduction ... This work presents a strategy to overcome long-standing complications of vertebroplasty and may contribute to safer and more effective treatment ...

6. inossia.com inossia.com/technology/

Technology V-Flex is manufactured by G21 S.r.l. and is the first bone cement using Inossia's cement softening technology to adapt it to osteoporotic bone.