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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COMPLETED
34 participants
OBSERVATIONAL
2016-05-24
2020-07-09
Brief Summary
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Detailed Description
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Patients will be screened for eligibility and subgroupings. Informed consent will be obtained from those who meet screening criteria and are interested in participating in the study.
Sites will be asked to enroll subjects according to past treatment, with the Fibulock™ intramedullary nail for unstable fibula fracture. The sites will enroll subjects in the study based on inclusion/exclusion criteria.
Patient pre-operative, intra-operative and post-operative records will be reviewed retrospectively. Once enrolled, subjects will undergo an evaluation of fracture outcome and complete a VAS pain score, SF-12, and Foot Function Index at 26 weeks and again at 52 weeks post-treatment.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Pilon Fractures
Patients who are implanted with Fibulock and have a Pilon fracture
Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures
High Risk Patients
Patients who are implanted with Fibulock and are at high risk of complications from ankle surgery due to conditions such as diabetes, advanced age or osteoporosis
Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures
Otherwise Healthy Patients
Patients implanted with Fibulock who are healthy other than their ankle fracture
Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures
Interventions
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Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures
Eligibility Criteria
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Inclusion Criteria
* Must be less than 31 weeks post-implantation
* Must have received surgical treatment with the Fibulock Intramedullary Nail for their unstable fibula - fracture
* Male or female greater than or equal to 18 years of age and skeletally mature.
* Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
* Ability to understand and provide written authorization for use and disclosure of personal health information.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Arthrex, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Terrence Philbin, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Foot & Ankle
Selene Parekh, MD
Role: PRINCIPAL_INVESTIGATOR
NCOC
Chris Hodgkins, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Health South Florida, Inc.
Locations
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Baptist Health South Florida
Miami, Florida, United States
NCOC
Durham, North Carolina, United States
Orthopedic Foot & Ankle Center
Westerville, Ohio, United States
Countries
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Other Identifiers
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FIB-001
Identifier Type: -
Identifier Source: org_study_id
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