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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011523 |
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Date of registration:
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03/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective, observational, multicenter clinical investigation evaluating the clinical outcomes of tibial and/or ankle fractures stabilizedby the temporary external fixator Galaxy UNYCO System
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Scientific title:
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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 |
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Date of first enrolment:
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28/02/2017 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00011523 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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France
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Germany
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Italy
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Contacts
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Name:
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Peter
Biberthaler |
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Address:
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Ismaninger Straße 22
81675
München
Germany |
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Telephone:
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+49 089 41402126 |
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Email:
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peter.biberthaler@mri.tum.de |
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Affiliation:
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Technische Universität MünchenHospital: Klinikum rechts der IsarDepartment: Klinik und Poliklinik for Unfallchirurgie |
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Name:
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Chlodwig
Kirchhoff |
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Address:
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Ismaninger Straße 22
81675
München
Germany |
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Telephone:
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+49 089 41402126 |
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Email:
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Chlodwig.Kirchhoff@mri.tum.de |
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Affiliation:
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Technische Universität MünchenHospital: Klinikum rechts der IsarDepartment: Klinik und Poliklinik for Unfallchirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Group 1: Male or female adult patients who have been diagnosed with a tibial and/or ankle fracture/s that do not allow immediate definitive treatment and having a regular indication for surgical intervention with the temporary external fixator Galaxy UNYCO System are planned to be enrolled.
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Primary Outcome(s)
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The clinical performance of the Galaxy UNYCO System will be assessed by the following primary efficacy endpoints:
- proportion of patients who, in the sole and therefore qualitative judgment of the Investigator, considered at a time just before device removal have either maintained reduction or have lost a clinically significant degree of reduction from the device application;
- proportion of patients who, on the basis of a quantitative software analysis performed on radiographic measurements, considered at a time just before device removal have either maintained reduction or have lost a clinically significant degree of reduction from the device application.
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Secondary Outcome(s)
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And the following secondary efficacy endpoints:
- extraction torque of the monocortical screws measured at device removal;
- intraoperative application time;
- number of intraoperative fluoroscopy shots.
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Source(s) of Monetary Support
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Orthofix Srl
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Ethics review
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Status: Approved
Approval date: 18/10/2016
Contact:
ethikkommission@mri.tum.de
Ethikkommission der Fakultät für Medizin der Technischen Universität München
+49-89-41404371
ethikkommission@mri.tum.de
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