Effectiveness Of The Fibulock Intramedullary Nail

Arthrex, Inc.34 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Fibula Fracture

Interventions

FibulockDEVICE

Fibulock intramedullary implant will be used to repair fibula fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * An unstable fibula fracture. * 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: * Patients who are not implanted with a Sonoma Fibulock IM Nail

Locations (3)

Baptist Health South Florida

Miami, Florida, United States

NCOC

Durham, North Carolina, United States

Orthopedic Foot & Ankle Center

Westerville, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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