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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Vertebral Compression Fracture

Intervention / Treatment
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* Device: V-Flex
* Device: V-Steady


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-Flex<br>Bone cement including Inossia Cement Softener | Device: V-Flex<br>* Bone cement including Inossia Cement Softener. Treatment for vertebral compression fracture<br>* Other names: Kyphoplasty;|
| Active Comparator: V-Steady<br>Bone Cement alone | Device: V-Steady<br>* Bone Cement alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New fractures | Assess the effectiveness after administration of the investigational device compared to PMMA as measured by change of new fractures. | 1 year | 
| Location of fractures | Assess the location of new fractures: adjacent or non-adjacent to the treated vertebral or re-fractures of the treated vertebra after administration of the investigational device compared to PMMA. | 1 year | 
| Timing of fractures | Assess the timing of adjacent, non-adjacent and re-fractures of the treated vertebra after administration of the investigational device compared to PMMA. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by VAS | Assess the change in back pain at time points 5 days, 3 months, 12 months after administration of the investigational device compared to PMMA as measured by Visual Analogue Scale (VAS): scale 0-100, where 0 is no pain and 100 is the worst pain imaginable | 12 months | 
| Function by ODI | Assess the change in function at time points 5 days, 3 months, 12 months after administration of the investigational device compared to PMMA as measured by Oswestry Disability Index (ODI): scale 0-100% where a higher score means a worse outcome | 12 months | 
| Health related quality of life by SF-12 | Assess the change in health related quality of life at time points 5 days, 3 months, 12 months after administration of the investigational device compared to PMMA as measured by SF-12: scale 0-100 where a higher score means a better outcome | 12 months | 
| Safety measured by adverse events | Asses the safety of Inossia™ Cement Softener as measured by adverse events | 12 months | 
| Hospital Beds | Record the number of hospital bed days (within hospital, nursing home, etc.) during the first week | 1 week | 
| The vertebral height | The vertebral height at 12 months compared to baseline by X-ray (Average Mild Vertebral Body Height) | 12 month | 
| Analgesic use | Record the analgesic use and compare to the WHO analgestic ladder | 12 months | 
| Osteoporotic treatment regimen checklist | Record the osteoporotic treatment regimen | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertebral compression fracture, bone cement, vertebroplasty, kyphoplasty, osteoporosis, softener