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

NCT05676320 | Active Not Recruiting

• 1 other identifier: SOFTBONE 1512:1
• Study Type: interventional
• Target: 203
• Locations: 4 countries
• Sites: 9

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).

Conditions

Vertebral Compression Fracture

Keywords

vertebral compression fracture; bone cement; vertebroplasty; kyphoplasty; osteoporosis; softener

Outcome Measures

Primary Outcomes (3)

• New fractures

  To assess the effectiveness after administration of V-Flex compared to V-Steady as measured by reduction of new radiologically confirmed 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 Outcomes (8)

• 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

• Hospital Beds

  1 week

Study Arms (2)

V-Flex

EXPERIMENTAL

Bone cement including Inossia® Cement Softener

Device: V-Flex

V-Steady

ACTIVE COMPARATOR

Bone Cement alone

Device: V-Steady

Interventions

V-Flex DEVICE

Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture

V-Flex

V-Steady DEVICE

Bone Cement alone

V-Steady

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pacemaker

Sponsors & Collaborators

• Inossia AB: lead
• EIT Health: collaborator
• Uppsala University: collaborator

Study Sites (9)

Beam Radiology

Calgary, Alberta, Canada

Location

Mannheim University Hospital

Mannheim, Germany

Location

Hospital in Mechernich

Mechernich, Germany

Location

Lodz University Hospital

Lodz, Poland

Location

Clínico San Carlos

Madrid, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Puerta de Hierro

Madrid, Spain

Location

Hopsital Medina del Campo

Medina del Campo, Spain

Location

University Hospital in Valladolid

Valladolid, Spain

Location

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MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Noriega

  University Hospital in Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 9, 2023
• Study Start: March 11, 2021
• Primary Completion: October 20, 2025
• Study Completion: May 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); ES (5); DE (2); PL (1)