A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures

Официальное название

A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• 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) [Срок оценки: 6 months]
• Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline [Срок оценки: 6 months]
• Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety) [Срок оценки: 1 month]

Вторичные конечные точки (7)

• Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU. [Срок оценки: 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. [Срок оценки: Post-Operative, ost-Operative, 1 Month FU, 6 Months FU and 12 Months FU.]
• Reduction in vertebral fracture-related pain (measured by the 11-point Numerical Pain Rating Scale (NPRS)) [Срок оценки: Discharge, 1, 3, 6 and 12 Months FU compared to baseline.]
• Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline. [Срок оценки: 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 [Срок оценки: 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline]
• Device-related serious adverse events assessed at 12- and 24- months post-procedure. [Срок оценки: 12 months FU, 24 months FU]
• All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure. [Срок оценки: 12 Months FU, 24 Months FU]

Критерии участия

Критерии включения

• Subject is ≥ 21 to ≤ 85 years old.
• 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
• Subject has a NPRS back pain score of ≥5
• Subject is a candidate for surgical intervention based on investigator opinion
• Subject has a body Mass Index (BMI) < 35
• Subject is mentally capable of complying with trial protocol requirements for the duration of the study
• Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent

Критерии исключения

• Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
• 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).
• Spondylolisthesis > Grade 1 at target vertebral body(s)
• Local kyphotic angle > 30°
• Pre-existing vertebral fracture prior to the index fracture
• Subjects that require anterior stabilization of the index fracture
• Fracture to the pedicle based on radiographic evaluation
• Spinal cord compression or canal compromise requiring decompression
• Severe back pain due to causes other than acute fracture with NPRS score>5
• The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
• Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
• Pre-existing neurological deficit, radiculopathy or myelopathy
• 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
• Contraindications to both MRI and radionuclide bone scan
• Concurrent participation in another clinical study which could potentially interfere with the outcome of this study.
• A life expectancy less than the study duration or undergoing palliative care
• Subject non-ambulatory prior to fracture
• Allergy to any components of the device/instruments used during the procedure
• Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
• Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)
• Any evidence of alcohol or drug abuse.
• Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for >3 months)
• The subject is currently on anti-cancer therapy or anti-HIV therapy
• Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Wilhelmsburger Krankenhaus Groß-Sand — Hamburg
• Krankenhaus Mechernich — Mechernich

Франция · 1 центр

• Centre Hospitalier Métropole de Savoie — Chambéry

Идентификаторы

NCT: NCT07301749 · CIP-VS02-EU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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