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V-Steady + V-Flex for Spinal Fractures (SOFTBONE Trial)
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.
SOFTBONE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOFTBONE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SOFTBONE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: V-Flex
- Group 2: V-Steady
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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