Vertebral Compression Fracture
Conditions
Keywords
VCF, EXPAND, vertebral stabilization, fracture, trauma, osteoporosis, expandable implant
Brief summary
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults. Up to 8 hospitals in Europe will take part in the study. All participants will receive treatment with the VCFix device. The treatment will be provided according to the intended use of the device and may be performed either with or without the use of a special bone cement. Participants will be assigned to one of two study groups before treatment: Cementless group: the VCFix device is implanted without bone cement. Cemented group: the VCFix device is implanted together with bone cement. The study will assess how well the treatment works and how safe it is. Researchers will evaluate: Changes in back pain 6 months after treatment compared with before treatment. Changes in daily functioning and ability to perform everyday activities 6 months after treatment compared with before treatment. Whether any serious device-related complications occur during the first month after treatment. The results will help determine whether treatment with the VCFix device provides benefits for patients with vertebral compression fractures while maintaining an acceptable safety profile.
Interventions
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.
Sponsors
Amber Implants B.V.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study comprises two predefined cohorts, assigned based on protocol-specific criteria applied prior to treatment: * a cementless cohort, where the device is implanted without polymethylmethacrylate (PMMA) bone cement * a cemented cohort, where the device is used in conjunction with PMMA bone cement Outcomes for each cohort will be evaluated independently against an external control. No direct comparison between the study cohorts is planned.
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 21 to ≤ 85 years old. 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
1. Neoplasms with posterior involvement and/or presence of a mass within the spinal canal 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of more than 2 points in vertebral fracture-related pain intensity at 6 months after the index procedure compared to baseline as measured by a 11-point Numerical Pain Rating Scale (NPRS) | 6 months |
| Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline | 6 months |
| Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety) | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU. | Post-Operative, 1Month FU, 6 Months FU, 12 Months FU | — |
| Kyphotic angle and Cobb angle improvement at Post-Operative, 1 Month FU, 6 Months FU and 12 Months FU. | Post-Operative, ost-Operative, 1 Month FU, 6 Months FU and 12 Months FU. | Kyphotic angle and Cobb angle improvement |
| Reduction in vertebral fracture-related pain (measured by the 11-point Numerical Pain Rating Scale (NPRS)) | Discharge, 1, 3, 6 and 12 Months FU compared to baseline. | Reduction in vertebral fracture-related pain |
| Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline. | Discharge, 1, 3, 6 and 12 months FU | — |
| Improvement of Health-related quality of life (HRQoL) measured by EuroQol 5-Dimension Scale (EQ-5D-5L) at 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline | 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline | Improvement of Health-related quality of life (HRQoL) |
| Device-related serious adverse events assessed at 12- and 24- months post-procedure. | 12 months FU, 24 months FU | Device-related serious adverse events |
| All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure. | 12 Months FU, 24 Months FU | — |
Countries
France, Germany
Contacts
CONTACTClinical Research Manager
Outcome results
None listed