Effectiveness Of The Fibulock Intramedullary Nail

Completed

• Conditions: Fibula Fracture
• Interventions: Device: Fibulock

• Registration Number: NCT02688296
• Lead Sponsor: Arthrex, Inc.

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-23
• Study Start: 2016-05-24
• Primary Completion: 2020-07-09
• Study Completion: 2020-07-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pilon Fractures	Fibulock	Patients who are implanted with Fibulock and have a Pilon fracture
Otherwise Healthy Patients	Fibulock	Patients implanted with Fibulock who are healthy other than their ankle fracture
High Risk Patients	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

Primary Outcome Measures

Name	Time	Method
Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays	26 weeks	Lateral and mortice view x-rays at 26 weeks

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	26 weeks and 52 weeks	Patient self reported pain intensity.
Foot Function Index	26 weeks and 52 weeks	The Foot Function Index (FFI) is used to measure the impact of foot pathology on function in terms of pain, disability and activity restriction.
SF 12	26 weeks and 52 weeks	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.

Trial Locations

Locations (3)

NCOC; 🇺🇸 Durham, North Carolina, United States

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

Orthopedic Foot & Ankle Center; 🇺🇸 Westerville, Ohio, United States