V-Steady + V-Flex for Spinal Fractures

(SOFTBONE Trial)

Recruiting in Łódź (>99 mi)

+6 other 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

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 5 8 9}

Research Team

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.

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

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
• 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Properties of an injectable low modulus PMMA bone cement for osteoporotic bone. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Progressive collapse of PMMA-augmented vertebra: a report of three cases. [2008]

3. Malaysia pubmed.ncbi.nlm.nih.gov

Effect of Polymethylmethacrylate-Hydroxyapatite Composites on Callus Formation and Compressive Strength in Goat Vertebral Body. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Does the cement stiffness affect fatigue fracture strength of vertebrae after cement augmentation in osteoporotic patients? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Response of fractured osteoporotic bone to polymethylacrylate after vertebroplasty: case report. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Two novel high performing composite PMMA-CaP cements for vertebroplasty: An ex vivo animal study. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the particle release of porous PMMA cements during curing. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Intravertebral clefts in osteoporotic compression fractures of the spine: incidence, characteristics, and therapeutic efficacy. [2022]

9. United States 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. [2011]