Amber Implants B.V.
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.
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 * T…
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 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.