PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
NCT ID: NCT05943574
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
91 participants
OBSERVATIONAL
2024-06-10
2025-06-30
Brief Summary
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The primary objective is the assessment of performance by analyzing fracture healing.
The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
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Detailed Description
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One site will be involved in this study. The aim is to include a maximum of 91 consecutive series cases who received the XtraFix® Small External Fixation System at the Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" (Naples, Italy) starting from 2019 until 2021. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preoperative, intraoperative, immediate post-operative and device removal visit will be available in medical notes and collected retrospectively. During a follow up phone call at least 1 year post-operative the subject will be asked to complete a patient questionnaire and a clinical assessment of the fracture healing will be done. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients who received the XtraFix® Small External Fixation System
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Specifically, the system is intended for temporary stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
* Revision surgeries will also be included in the study.
* In this study we will only collect data on wrist and proximal humerus fractures.
Exclusion Criteria
* Active or suspected infection
* Conditions that limit the patient's ability and/or willingness to follow instructions during the healing process
* Inadequate skin, bone, or neurovascular status
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Hassan Achakri
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"
Naples, Campania, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDRG2017-89MS-147T
Identifier Type: -
Identifier Source: org_study_id
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