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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
Pain score ≥ 40 mm measured by VAS correlating to at least one of the fracture levels at the screening visit
SF-12PCS Index < 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

SOFTBONE Trial 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.Check my eligibility
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.See study design
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.

SOFTBONE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain level is high, scoring 40 or more on the pain scale.
Select...
My health score is below 80 on the SF-12PCS.
Select...
My back pain significantly affects my daily activities.
Select...
I need regular painkillers due to pain from a fracture affecting my daily life.
Select...
I have up to one spine fracture between the mid-back and lower back confirmed by an MRI or bone scan.
Select...
My spine's affected area is compressed but not more than 60% compared to a normal part.

SOFTBONE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Location of fractures
New fractures
Timing of fractures
Secondary outcome measures
Analgesic use
Function by ODI
Health related quality of life by SF-12
+5 more

SOFTBONE 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

Find a Location

Who is running the clinical trial?

Uppsala UniversityOTHER
478 Previous Clinical Trials
2,801,157 Total Patients Enrolled
Inossia ABLead Sponsor
EIT HealthOTHER
11 Previous Clinical Trials
4,580 Total Patients Enrolled

Media Library

V-Flex (Bone Cement) Clinical Trial Eligibility Overview. Trial Name: NCT05676320 — N/A
Vertebral Compression Fractures Research Study Groups: V-Flex, V-Steady
Vertebral Compression Fractures Clinical Trial 2023: V-Flex Highlights & Side Effects. Trial Name: NCT05676320 — N/A
V-Flex (Bone Cement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676320 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current recruitment rate for this experimental research?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients - the listing was first posted on March 11th 2021 and recently updated in January 6th 2023. In total, 150 participants need to be sourced from one site for enrollment purposes."

Answered by AI

What results are researchers hoping to observe from this research?

"Over the course of 12 months, researchers will measure this trial's efficacy in preventing fractures. Secondary objectives include evaluating changes in function (measured by Oswestry Disability Index), health related quality of life (using SF-12) and hospital bed days used during week one post administration."

Answered by AI

Is this trial actively seeking participants?

"Clinicaltrials.gov confirms that this medical trial is actively recruiting participants, having been first posted on March 11th 2021 and most recently revised on January 6th 2023."

Answered by AI
~27 spots leftby Dec 2024