A prospective, observational, multicenter clinical investigation evaluating the clinical outcomes of tibial and/or ankle fractures stabilizedby the temporary external fixator Galaxy UNYCO System - OCI 1501

Orthofix Srl0 个研究点目标入组 28 人开始时间: 2017年1月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patient will be eligible for inclusion in the investigation if he/she:
•- is at least 18 years old at time of ICF signature;
•- is compliant in signing ICF;
•- has a tibial and/or ankle fracture/s requiring surgical management with an external fixator for the temporary stabilization of bone fragments prior to definitive treatment in trauma or orthopedic condition/procedures, such as:
•- comminuted open or closed tibial fractures
•- damage control orthopedics for fractures with severe soft tissue injuries
•- peri-prosthetic or peri-implant fractures
•- joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
•- intermediate stabilization in staged surgery
•- infected non-union pending second stage treatment bone-loss or other reconstructive procedures
•- has a regular indication for surgical intervention with Galaxy UNYCO System components according to the manufacturer’s instruction for use and in accordance with the individual Investigator judgment and normal practice parameters and decision making

•Patient will be excluded from participation in the investigation if he/she:
•-has a medical condition that is a contraindication according to the manufacturer’s instruction for use, that include:
•- patients with mental or physiological conditions who are unwilling or incapable of following postoperative care instructions
•- patients with severe osteoporosis
•- patients with malignancy either a primary or as metastic lesion or lesions in the fracture area
•- patients with foreign body sensitivity;
•-has any conditions that in the Investigator’s opinion may interfere with the study execution or due to which the patient should not participate for safety reasons;
•- requires the application of, or has already in-situ the application of concomitant devices that cannot be safely removed and are therefore considered impermissible in accordance with the manufactiurer’s guidelines;
•- is participating in other clinical trials or has taken part in any clinical study in the last 3 months;
•- is likely to be lost to follow up.

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