Clinical trial NCT05676320: Investigating Bone Cement With or Without Inossia™ Cement Softener for Vertebral Compression Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vertebral Compression Fracture
Keywords: vertebral compression fracture
bone cement
vertebroplasty
kyphoplasty
osteoporosis
softener
Lead sponsor: Inossia AB
Sponsor class: INDUSTRY
Collaborators: name: EIT Health
name: Uppsala University
First posted: 2023-01-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 150 patients will be enrolled in the study.

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

Primary outcomes:
measure: New fractures
timeFrame: 1 year
measure: Location of fractures
timeFrame: 1 year
measure: Timing of fractures
timeFrame: 1 year
Secondary outcomes:
measure: Pain measured by VAS
timeFrame: 12 months
measure: Function by ODI
timeFrame: 12 months
measure: Health related quality of life by SF-12
timeFrame: 12 months
measure: Safety measured by adverse events
timeFrame: 12 months
measure: Hospital Beds
timeFrame: 1 week
measure: The vertebral height
timeFrame: 12 month
measure: Analgesic use
timeFrame: 12 months
measure: Osteoporotic treatment regimen checklist
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Beam Radiology
state: Alberta
city: Mannheim
country: Germany
facility: Mannheim University Hospital
city: Mechernich
country: Germany
facility: Hospital in Mechernich
city: Łódź
country: Poland
facility: Lodz University Hospital
city: Madrid
country: Spain
facility: Clínico San Carlos
city: Madrid
country: Spain
facility: Puerta de Hierro
city: Valladolid
country: Spain
facility: University Hospital in Valladolid
Study officials:
affiliation: University Hospital in Valladolid
name: David Noriega
role: PRINCIPAL_INVESTIGATOR
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