An observational study in Fibula Fracture, sponsored by Arthrex, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Arthrex, Inc. · Observational
The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulock™ Intramedullary Nail.
This is a retrospective/prospective, multi-site observational study, designed to evaluate the clinical outcomes and complication rates in subjects who were previously implanted with a Fibulock™ intramedullary nail.
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.
Arthrex, Inc. is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.
Exclusion Criteria:
Patients who are implanted with Fibulock and have a Pilon fracture
Device: Fibulock
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
Device: Fibulock
Patients implanted with Fibulock who are healthy other than their ankle fracture
Device: Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures
Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays
Lateral and mortice view x-rays at 26 weeks
Time frame: 26 weeks
Visual Analog Scale
Patient self reported pain intensity.
Time frame: 26 weeks and 52 weeks
SF 12
SF 12 is a Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.
Time frame: 26 weeks and 52 weeks
Foot Function Index
The Foot Function Index (FFI) is used to measure the impact of foot pathology on function in terms of pain, disability and activity restriction.
Time frame: 26 weeks and 52 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Fibula Fractures
Arthrex, Inc.