A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.

A vizsgálat adatai

Ki végzi

Amber Implants B.V.

Azonosító

NCT07920484

A regiszteradat frissítve

2026. november 5.

Eredeti leírás

This study is designed as a prospective, post-market, multi-center, single-arm study to collect real-world data of the VCFix Spinal System used in US clinical practice.A teljes eredeti leírásKevesebb

A Prospective, Multicenter, Post-Market Clinical Study Collecting Real-World Data of the VCFix Spinal System in Stand-Alone Configuration for Vertebral Augmentation (EXPAND-US)

This study is designed as a prospective, post-market, multi-center, single-arm study to collect real-world data of the VCFix Spinal System used in US clinical practice.

Approximately 5 centers in the US will enroll subjects with VCF in a non-randomized fashion, and VCFix will be used within its cleared purpose and indications for use.

The study has been designed to be methodologically compatible with the EU EXPAND (CIP-VS02-EU) study, thereby aiming for the pooling of data to the EU study. Data pooling will be pursued only as a sensitivity analysis if pre-specified similarity criteria are met. The US study provides meaningful real-world evidence regardless of pooling feasibility.

The targeted patient population, assessment schedule, and study endpoints are therefore similar to those of the EU EXPAND study.

Bevonási feltételek: 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 is diagnosed with, or has a suspected diagnosis of, severe osteoporosis, including low trabecular bone quality , and/or an oversized vertebral body as compared to implant size (e.g. relatively small pedicle requiring smaller implant size than desired for vertebral body size and/or fracture characteristics and location) 4. Subject has a NPRS back pain score of ≥5 5. Subject is a candidate for surgical intervention based on investigator opinion 6. Subject has a body Mass Index (BMI) < 35 7. Subject is mentally capable of complying with trial protocol requirements for the duration of the study 8. Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent.

Kizáró feltételek: Any pre-existing vertebral fracture prior to the index fracture; Previous spine surgery, balloon kyphoplasty or vertebroplasty, for any vertebral fracture; Concurrent participation in another clinical study which could potentially interfere with the outcome of this study; Subject non-ambulatory prior to fracture Allergy to any components of the device/instruments used during the procedure; 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; Patient known to be involved in medical litigation including Workmen's Compensation prior to the surgery; Pain due to any other condition that requires daily narcotic (opiates or opioids) medication; Irreversible coagulopathy or bleeding disorder; 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.); 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; 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°; 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); Pre-existing neurological deficit, radiculopathy or myelopathy; Contraindications to both MRI and Computed Tomography (CT) imaging; A life expectancy less than the study duration or undergoing palliative care; Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration.

ClinicalTrials.gov NCT07920484