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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 203
- Locations
- 9
- Primary Endpoint
- New fractures
Study Overview
Brief Summary
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
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 203 patients were enrolled in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
V-Flex
Bone cement including Inossia® Cement Softener
Intervention: V-Flex (Device)
V-Steady
Bone Cement alone
Intervention: V-Steady (Device)
Outcomes
Primary Outcomes
New fractures
Time Frame: 1 year
To assess the effectiveness after administration of V-Flex compared to V-Steady as measured by reduction of new radiologically confirmed fractures.
Timing of fractures
Time Frame: 1 year
Assess the timing of adjacent, non-adjacent and re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
Location of fractures
Time Frame: 1 year
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.
Secondary Outcomes
- Function by ODI(24 months)
- Pain measured by VAS(24 months)
- Health related quality of life by SF-12(24 months)
- Safety measured by adverse events(24 months)
- Analgesic use(24 months)
- Hospital Beds(1 week)
- The vertebral height(24 month)
- Osteoporotic treatment regimen checklist(24 months)