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Bone Cement
V-Steady + V-Flex for Spinal Fractures (SOFTBONE Trial)
N/A
Recruiting
Led By David Noriega
Research Sponsored by Inossia AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tested a new type of cement for treating spinal fractures caused by osteoporosis, to see if it is safe and effective.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include local reactions at the injection site like pain or infection; allergic reactions to materials used; bleeding; increased back pain; numbness or weakness due to nerve damage; cement leaking into surrounding areas causing complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Location of fractures
New fractures
Timing of fractures
Secondary study objectives
Analgesic use
Function by ODI
Health related quality of life by SF-12
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
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Who is running the clinical trial?
Uppsala UniversityOTHER
508 Previous Clinical Trials
3,197,819 Total Patients Enrolled
Inossia ABLead Sponsor
EIT HealthOTHER
11 Previous Clinical Trials
4,583 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have had a burst fracture.I have had vertebroplasty or kyphoplasty before.I do not have any ongoing infections.My back pain significantly affects my daily activities.My BMI is 40 or higher.I have a bleeding disorder but can still join if I'm on blood thinners.I need regular painkillers due to pain from a fracture affecting my daily life.I have had or am currently undergoing radiotherapy on my spine.I have up to one spine fracture between the mid-back and lower back confirmed by an MRI or bone scan.I have severe back issues due to injury or conditions causing nerve weakness.My spine's affected area is compressed but not more than 60% compared to a normal part.I have a painful spine fracture that hasn't improved with treatment in 6 months.My pain level is high, scoring 40 or more on the pain scale.My broken vertebra is caused by or suspected to be cancer.My health score is below 80 on the SF-12PCS.I can understand and follow the study's procedures and follow-up.
Research Study Groups:
This trial has the following groups:- Group 1: V-Flex
- Group 2: V-Steady
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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