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

Inossia

Status: Enrolling

Conditions: Vertebral Compression Fracture

Treatments: Device: V-Flex; Device: V-Steady

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05676320

SOFTBONE 1512:1

Details and patient eligibility

About

The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA bone cement is comparable to a PMMA bone cement alone (V-Steady).

Full description

The clinical investigation is a prospective, single-blind, controlled multi-center study of vertebral compression fractures treated by vertebroplasty or kyphoplasty with PMMA alone (V-Steady) or PMMA mixed with Inossia™ Cement Softener (V-Flex).

The overall purpose of conducting this study is to confirm the safety and efficacy of Inossia™ Cement Softener mixed with PMMA for augmentation of osteoporotic vertebral compression fractures and to verify that the V-Flex is, at least, comparable (non-inferior) to the PMMA products used today.

All eligible patients will be invited to participate in the study. A total of 150 patients will be enrolled in the study.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

V-Flex

Experimental group

Description:

Bone cement including Inossia Cement Softener

Treatment:

Device: V-Flex

V-Steady

Active Comparator group

Description:

Bone Cement alone

Treatment:

Device: V-Steady