NCT02688296

Effectiveness Of The Fibulock Intramedullary Nail

The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fibula Fracture

Interventions

Type	Name	Description
DEVICE	Fibulock	Fibulock intramedullary implant will be used to repair fibula fractures

Timeline

• Start date: 2016-05-24
• Primary completion: 2020-07-09
• Completion: 2020-07-09
• First posted: 2016-02-23
• Last updated: 2021-01-20

Locations

3 sites across 1 country: United States