Evaluating bone cement with or without a softener for treating vertebral compression fractures

A Multicentre, Single-blind, RCT to Document the Safety and Efficacy of the Use of a Bone Cement With or Without Inossia™ Cement Softener for Patients With Vertebral Compression Fractures

This study is testing whether a new type of bone cement with a softener works better than the standard cement for treating painful spinal fractures in people with osteoporosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inossia AB (Industry-sponsored)
• Locations: 7 sites (Calgary, Alberta and 6 other locations)
• Trial ID: NCT05676320 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the safety and efficacy of two types of bone cement, V-Flex (which includes Inossia™ Cement Softener) and V-Steady (standard PMMA), for treating osteoporotic vertebral compression fractures. The study is a prospective, single-blind, controlled multi-center trial involving patients who have symptomatic fractures. A total of 150 patients will be enrolled, and their outcomes will be compared to determine if the addition of the cement softener provides any advantages over the standard treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals with symptomatic osteoporotic vertebral compression fractures localized between Th5 and L5 who have not responded to medical treatment within the last six months.

Not a fit: Patients with multiple vertebral compression fractures or those who have already undergone treatment for their fractures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from vertebral compression fractures, potentially enhancing pain relief and recovery.

How similar studies have performed: Previous studies have shown promising results with similar approaches in treating vertebral compression fractures, indicating potential for success in this investigation.

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

Where this trial is running

Calgary, Alberta and 6 other locations

• Beam Radiology — Calgary, Alberta, Canada (Not_yet_recruiting)
• Mannheim University Hospital — Mannheim, Germany (Recruiting)
• Hospital in Mechernich — Mechernich, Germany (Recruiting)
• Lodz University Hospital — Łódź, Poland (Recruiting)
• Clínico San Carlos — Madrid, Spain (Recruiting)
• Puerta de Hierro — Madrid, Spain (Recruiting)
• University Hospital in Valladolid — Valladolid, Spain (Recruiting)

Study contacts

• Principal investigator: David Noriega — University Hospital in Valladolid
• Study coordinator: Malin K Nilsson, PhD

Conditions Vertebral Compression Fracture; vertebral compression fracture; bone cement; vertebroplasty; kyphoplasty; osteoporosis; softener