A prospective, observational, multicenter clinical investigation evaluating the clinical outcomes of tibial and/or ankle fractures stabilizedby the temporary external fixator Galaxy UNYCO System
Organizational Data
- DRKS-ID:
- DRKS00011523
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-01-03
- Last update in DRKS:
- 2022-08-04
- Registration type:
- Prospective
Acronym/abbreviation of the study
OCI 1501
URL of the study
No Entry
Brief summary in lay language
This is an international, multicentric and observational clinical study. The observed medical device, which is the Galaxy UNYCO System, is CE marked and is already used by the participating hospitals in everyday clinical practice. It is an external fixator for temporary stabilization of tibial and ankle fractures. The clinical study is planned, organized and financed by Orthofix Srl (Bussolengo, Verona - Italy), which is the sponsor. The aim of this clinical study is to collect clinical data on the medical device Galaxy UNYCO System from a representative group of patients and treating physicians. The study is expected to be conducted at 5-8 hospitals in Europe and a total of about 60 people with a tibial and / or ankle fracture will participate. The recruitment phase is planned for a period of twelve months. Each treated patient will participate in the study for approximately six months until the last follow-up visit. Therefore, the active study phase is about 18 months.
Brief summary in scientific language
This clinical investigation is a post-market, prospective, observational, multicenter and international study. The investigational device, namely the Galaxy UNYCO System, is CE marked and already used as part of the normal clinical practice of the participating investigational sites. Galaxy UNYCO System is a class IIb and CE marked medical device releasedon the European market by Orthofix Srl in August 2014. The Galaxy UNYCO System is an external fixator for the temporary stabilization of tibial and/or ankle fractures. It is a modular system including multiscrew clamps, rods and monocortical screws, whichare the most innovative components: they have been designed to avoid entry into the medullary canal and they carry the potential of avoiding contamination of this area prior to subsequent definitive treatment. The proposed observational clinical investigation fully complied with and follows all proper pre-market conformity assessment processes required to obtain a CE mark. This study has been planned as part of the Orthofix Srl post-market active surveillance strategy for the collection of data on both the clinical performance and the safety of the Galaxy UNYCO System in a representative population of patients and users. The rationale of the proposed study is to supplement, update and enhance the pre-market clinical evaluation of the Galaxy UNYCO System with real-time prospectively collected data arising from the full breadth of clinical data generated in the end-user setting. The objectives of the proposedstudy are to assess: - the clinical performance (intended as the ability to maintain fracture reduction from the time of application until removal without clinically significant changes in bone alignment and position) and - the safety of the Galaxy UNYCO System during the temporary stabilization of tibial and/or ankle fractures.
Health condition or problem studied
- Free text:
- 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
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- 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.
- Secondary outcome:
- And the following secondary efficacy endpoints: - extraction torque of the monocortical screws measured at device removal; - intraoperative application time; - number of intraoperative fluoroscopy shots.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- France
- Germany
- Italy
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Hospital: Groupe Hospitalier Universitaire Pitié Salpêtrière Department: Chirurgie Orthopédique et Traumatologique Paris
- University medical center Institution: Technische Universität München Hospital: Klinikum rechts der Isar Department: Klinik und Poliklinik for Unfallchirurgie München
- Medical center Hospital: Hôpital d'instruction des armées Percy Department: Chirurgie orthopédique Clamart
- University medical center Institution: Universitätsklinikum Freiburg Department: Klinik für Orthopädie und Unfallchirurgie Freiburg
- University medical center Institution: A.O.U. I. di Verona Hospital: Polo Chirurgico “P. Confortini” Ospedale Civile Maggiore Borgo Trento Department: U.O.C. Ortopedia e Traumatologia B Verona
- University medical center Institution: A.O.U. Consorziale Policlinico Hospital: Policlinico "Giovanni XXIII" Department: U.O. di Ortopedia e Traumatologia I e II Universitaria Bari
Recruitment period and number of participants
- Planned study start date:
- 2017-01-15
- Actual study start date:
- 2017-02-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-03-23
- Target Sample Size:
- 60
- Final Sample Size:
- 28
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Orthofix SrlVia delle Nazioni, 937012 BussolengoItaly
- Telephone:
- +39 045 6719061
- Fax:
- + 39 045 6719380
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Technische Universität MünchenHospital: Klinikum rechts der IsarDepartment: Klinik und Poliklinik for UnfallchirurgieUniv.-Prof. Dr. med. Peter BiberthalerIsmaninger Straße 2281675 MünchenGermany
- Telephone:
- +49 089 41402126
- Fax:
- +49 089 41404890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Technische Universität MünchenHospital: Klinikum rechts der IsarDepartment: Klinik und Poliklinik for UnfallchirurgiePD Dr Med Chlodwig KirchhoffIsmaninger Straße 2281675 MünchenGermany
- Telephone:
- +49 089 41402126
- Fax:
- +49 089 41404890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Technische Universität MünchenHospital: Klinikum rechts der IsarDepartment: Klinik und Poliklinik for UnfallchirurgieUniv.-Prof. Dr. med. Peter BiberthalerIsmaninger Straße 2281675 MünchenGermany
- Telephone:
- +49 089 41402126
- Fax:
- +49 089 41404890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Orthofix SrlVia delle Nazioni, 937012 BussolengoItaly
- Telephone:
- +39 045 6719061
- Fax:
- + 39 045 6719380
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Medizin der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41404371
- Fax:
- +49-89-41404199
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-06-09
- Ethics committee number:
- 282/16 S
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-10-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry