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

Vertebral Compression Fracture Clinical Trial

— SOFTBONE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676320
• Other study ID #: SOFTBONE 1512:1
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Inossia AB
• Contact: Malin K Nilsson, PhD
• Phone: +46702688674
• Email: malin.nilsson[@]inossia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Vertebral Compression Fracture

Intervention

Device:
• V-Flex
Bone cement including Inossia Cement Softener. Treatment for vertebral compression fracture
• V-Steady
Bone Cement alone

Locations

Country	Name	City	State
Canada	Beam Radiology	Calgary	Alberta
Germany	Mannheim University Hospital	Mannheim
Germany	Hospital in Mechernich	Mechernich
Poland	Lodz University Hospital	Lódz
Spain	Clínico San Carlos	Madrid
Spain	Puerta de Hierro	Madrid
Spain	University Hospital in Valladolid	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Inossia AB	EIT Health, Uppsala University

Countries where clinical trial is conducted

Canada,  Germany,  Poland,  Spain, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New fractures	Assess the effectiveness after administration of the investigational device compared to PMMA as measured by change of new fractures.	1 year
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Safety measured by adverse events	Asses the safety of Inossia™ Cement Softener as measured by adverse events	12 months
Secondary	Hospital Beds	Record the number of hospital bed days (within hospital, nursing home, etc.) during the first week	1 week
Secondary	The vertebral height	The vertebral height at 12 months compared to baseline by X-ray (Average Mild Vertebral Body Height)	12 month
Secondary	Analgesic use	Record the analgesic use and compare to the WHO analgestic ladder	12 months
Secondary	Osteoporotic treatment regimen checklist	Record the osteoporotic treatment regimen	12 months