The EU Registry for the IlluminOss® Bone Stabilization System - EU Registry

IlluminOss Medical, Inc.0 个研究点目标入组 72 人开始时间: 待定最近更新: 2024年4月29日

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•All patients who received the device under compassionate use or palliative care conditions will be asked to participate in the registry (retrospective). In addition, patients who have broken a phalange, metacarpal, distal radius, radius, ulna, clavicle, olecranon and/or fibula and will be treated with an IlluminOss device will be asked to participate in the registry (prospective).

•Contra-indications:
•1.Skeletally immature men and women
•2.Patients with distant foci of infections with may spread to the implant site.
•3.Patients allergic to implant materials or dental glue
•4. An intramedullary canal smaller than 3,5 mm (diameter) at site of the fracture.
•5. Uncooperative patient or patient with neurological disorder, incapagle of following directions.
•6. Patients with concomitant metabolic disorders which may impair bone formation.
•7. Patients with osteomalacia
•8. Patients with distant foci of infections with may spread to the implant site.
•9. Patients with marked bone loss or bone resorption.
•10. Vaccular insufficiency, muscleatrophy or neuromuscularcular diseases.
•11. Patients with open fractures with severe contamination
•12.Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
•13.Patients where the delivery sheath is unable to pass fracture after adequate reduction and alignment.

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