A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures.
NCT ID: NCT07301749
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
103 participants
INTERVENTIONAL
2025-11-04
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VCFix Spinal System
VCFix Spinal System in stand-alone configuration
The distinguishing features of this inetrvention reside in:
1. In situ adjustment and maintenance of the height and angle of the device that allows expansion of the fractured VB in the cranio-caudal direction to realign the vertebral endplates and correct kyphosis.
2. The complex titanium perforated structure with optimized surface roughness that allows possible bone attachment, thereby permitting natural healing of the bone and potentially providing more stability to the device and the treated vertebra over time.
3. The ability to likely secure and reinforce the vertebra without using PMMA bone cement, avoiding all the symptomatic and asymptomatic side effects of bone cement.
4. The ability to connect the posterior to the anterior column of the spine through the pedicle screw component of the VCFix implant, therefore improving the biomechanical load distribution and consequently the ability to stabilize more severe fractures.
Interventions
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VCFix Spinal System in stand-alone configuration
The distinguishing features of this inetrvention reside in:
1. In situ adjustment and maintenance of the height and angle of the device that allows expansion of the fractured VB in the cranio-caudal direction to realign the vertebral endplates and correct kyphosis.
2. The complex titanium perforated structure with optimized surface roughness that allows possible bone attachment, thereby permitting natural healing of the bone and potentially providing more stability to the device and the treated vertebra over time.
3. The ability to likely secure and reinforce the vertebra without using PMMA bone cement, avoiding all the symptomatic and asymptomatic side effects of bone cement.
4. The ability to connect the posterior to the anterior column of the spine through the pedicle screw component of the VCFix implant, therefore improving the biomechanical load distribution and consequently the ability to stabilize more severe fractures.
Eligibility Criteria
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Inclusion Criteria
2. Single vertebral fracture which meets all of the following criteria:
* Type A fractures from AO spine classification (compression injuries);
* Vertebral fracture located in the thoracic and lumbar regions of the spine
* Fracture age \< 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
* Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 60% based on radiographic evidence
* Target VB has appropriate anatomy, i.e. suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before surgery
3. Subject has a NPRS back pain score of ≥5
4. Subject is a candidate for surgical intervention based on investigator opinion
5. Subject has a body Mass Index (BMI) \< 35
6. Subject is mentally capable of complying with trial protocol requirements for the duration of the study
7. Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent
Exclusion Criteria
2. Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction).
3. Spondylolisthesis \> Grade 1 at target vertebral body(s)
4. Local kyphotic angle \> 30°
5. Pre-existing vertebral fracture prior to the index fracture
6. Subjects that require anterior stabilization of the index fracture
7. Fracture to the pedicle based on radiographic evaluation
8. Spinal cord compression or canal compromise requiring decompression
9. Severe back pain due to causes other than acute fracture with NPRS score\>5
10. The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
11. Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
12. Pre-existing neurological deficit, radiculopathy or myelopathy
13. Pre-existing condition or significant co-morbidity:
* Uncontrolled diabetes (HbA1c \>8%)
* Severe cardiopulmonary deficiencies
* Any other condition that would impact study outcome in the opinion of the investigator
14. Contraindications to both MRI and radionuclide bone scan
15. Concurrent participation in another clinical study which could potentially interfere with the outcome of this study.
16. A life expectancy less than the study duration or undergoing palliative care
17. Subject non-ambulatory prior to fracture
18. Allergy to any components of the device/instruments used during the procedure
19. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
20. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)
21. Any evidence of alcohol or drug abuse.
22. Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for \>3 months)
23. The subject is currently on anti-cancer therapy or anti-HIV therapy
24. Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration
21 Years
85 Years
ALL
No
Sponsors
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Amber Implants B.V.
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier Métropole de Savoie
Chambéry, , France
Wilhelmsburger Krankenhaus Groß-Sand
Hamburg, , Germany
Krankenhaus Mechernich
Mechernich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Unité de Recherche Clinique, Dr.
Role: primary
Neurosurgery Department
Role: primary
Orthopaedic Department
Role: primary
Other Identifiers
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CIP-VS02-EU
Identifier Type: -
Identifier Source: org_study_id