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 sites28 target enrollmentJanuary 3, 2017

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tibial and ankle fracture/s that do not allow immediate definitive treatment and having a regular indication for surgical intervention with a temporary external fixator
Sponsor: Orthofix Srl
Enrollment: 28
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

January 3, 2017

End Date

March 23, 2019

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

•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

•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.