Effectiveness Of The Fibulock Intramedullary Nail

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Fibula Fracture

Intervention / Treatment
-----------------
* Device: Fibulock


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilon Fractures<br>Patients who are implanted with Fibulock and have a Pilon fracture | Device: Fibulock<br>* Fibulock intramedullary implant will be used to repair fibula fractures<br>|
| High Risk Patients<br>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<br>* Fibulock intramedullary implant will be used to repair fibula fractures<br>|
| Otherwise Healthy Patients<br>Patients implanted with Fibulock who are healthy other than their ankle fracture | Device: Fibulock<br>* Fibulock intramedullary implant will be used to repair fibula fractures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Patient self reported pain intensity. | 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. | 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. | 26 weeks and 52 weeks |