Osteoporosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 21 and 85 years old
• You have a single spinal fracture caused by compression (not a burst or twisting injury) located in the mid or lower back area of the spine
• Your fracture is either less than 6 weeks old, or imaging shows it may still be possible to correct the bone position
• Imaging shows the affected vertebra has lost between 10% and 60% of its normal height at the front or middle section
• The size and shape of the bones around the fracture are suitable for the device being used in this trial (confirm with trial site)
• Your back pain rates at 5 or higher on a scale of 0 to 10
• Your doctor believes surgery is the right option for you
• Your Body Mass Index (BMI) is below 35
• You are able to understand and follow the study requirements for its full duration
• You are able to understand the risks and benefits and sign a written consent form

Who may not be able to join:

• Your fracture involves a tumor spreading to the back of the spine, or there is a growth inside the spinal canal
• Your fracture is older, has hardened, or cannot be repositioned (confirm with trial site)
• You have a condition where one spinal bone has slipped significantly over another (more than a mild degree)
• The angle of spinal curvature at the fracture site is greater than 30 degrees
• You had a previous spinal fracture before the current one being treated
• Your fracture requires surgery from the front of the spine to stabilize it
• The fracture extends into the small bony bridges (pedicles) that connect parts of the vertebra
• You have pressure on the spinal cord or spinal canal that needs to be surgically relieved
• You have severe back pain rated above 5 out of 10 caused by something other than the fracture
• You have been diagnosed with a slipped disc or severe narrowing of the spinal canal causing worsening weakness or paralysis
• You need to take strong pain medications (opiates or opioids) every day due to another condition
• You have existing nerve damage, nerve pain, or spinal cord problems before this fracture
• You have uncontrolled diabetes (blood sugar levels remain very high), serious heart or lung problems, or another major health condition that could affect the study results
• You are unable to have both an MRI scan and a bone scan
• You are currently participating in another clinical trial that could affect this study's results
• Your life expectancy is shorter than the length of this study, or you are receiving end-of-life care
• You were unable to walk on your own before the fracture occurred
• You have a known allergy to any materials used in the device or surgical instruments
• You have an active infection of the spine or anywhere in your body, including an unresolved urinary tract infection
• You have a bone disease other than osteoporosis (such as Paget's disease or brittle bone disease)
• There is evidence of alcohol or drug misuse
• You have been taking high-dose steroid medication (30 mg or more per day) for more than 3 months
• You are currently receiving cancer treatment or HIV treatment
• You are pregnant, or you could become pregnant and are unwilling to use contraception throughout the study

Important: Always verify eligibility with the trial site directly before applying.