Investigating Bone Cement With or Without Inossia™ Cement Softener for Vertebral Compression Fractures

Launched by INOSSIA AB · Jan 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of bone cement, V-Flex and V-Steady, to see how well they help patients with painful vertebral compression fractures, which are breaks in the spine often caused by osteoporosis. The researchers want to find out if adding a special softener to the bone cement makes it work better than using the cement alone. They are currently looking for participants aged 65 to 74 who have these fractures and are experiencing significant pain that affects their daily activities.

To be eligible, participants must be able to give informed consent and have a specific type of spinal fracture that hasn't improved with other treatments in the last six months. They should also have a certain level of pain and disability. If you join the study, you will receive either type of cement during a procedure to help stabilize your spine, and you will be closely monitored afterward to see how well it works and if there are any side effects. It's important to note that some people, such as those with certain medical conditions, recent injuries, or specific treatments, may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent obtained before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the patient, i.e. standard of care);
• • Symptomatic osteoporotic vertebral compression fracture without prior or not responding to medical treatment within 6 months;
• • Maximum of 1 level of vertebral compression fractures eligible for treatment localized at level Th5 to L5 and verified by MRI or bone scan;
• • Height reduction of the affected vertebra(e) with an anterior wall compression of not exceeding 60% compared to the nearest normal vertebral body determined by X-ray;
• • Have pain correlating to the fractured levels requiring regular analgesic intake and/or causing substantial disability of daily life;
• • Pain score ≥ 40 mm measured by VAS correlating to at least one of the fracture levels (scale 0 - 100 mm) at the screening visit;
• • Oswestry Disability Index \> 20 (0 - 100 scale);
• • SF-12PCS Index \< 80 (0 - 100 scale);
• • Patient with a communicative ability to understand the procedure and participate in the study and comply with the follow up program.
• Exclusion Criteria:
• • Patients below 18 years;
• • Any burst fracture;
• • Unstable fractures defined by neurological deficit or interspinous process widening as evaluated by the Investigator, as well as kyphosis \> 30°, translation \> 4 mm;
• • Established or suspected malignancy of the fractured vertebra. Hemangioma of the fractured vertebra;
• • High energy trauma or clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis as suggested by progressive weakness;
• • Have neurologic symptoms or deficits, or radiculopathy related to the fractured vertebrae;
• • Patients with extremely high BMI, i.e. BMI ≥ 40;
• • Previously treated with vertebroplasty or kyphoplasty;
• • Patients with concomitant diseases which may be worsened by invasive treatment of the fracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm), as judged by the Investigator
• • Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re- initiation of anticoagulants;
• • Active systemic infection or local skin infection at the puncture site;
• • Pregnancy or breast-feeding;
• • Patients with known chemical dependency or drugs or with a medical history of drug abuse;
• • Patients who are serving prison sentence;
• • Have participated in another investigational study within 30 days prior to inclusion
• • Pacemaker
• • Previous or active radiotherapy affecting the spine