Effectiveness Of The Fibulock Intramedullary Nail (Fibulock)

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

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.

Study Overview

• Status: Completed
• Conditions: Fibula Fracture
• Intervention / Treatment: Device: Fibulock

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • Baptist Health South Florida
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • NCOC
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Orthopedic Foot & Ankle Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pilon Fractures; Patients who are implanted with Fibulock and have a Pilon fracture	Device: Fibulock; Fibulock intramedullary implant will be used to repair fibula fractures
High Risk Patients; 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; Fibulock intramedullary implant will be used to repair fibula fractures
Otherwise Healthy Patients; Patients implanted with Fibulock who are healthy other than their ankle fracture	Device: Fibulock; Fibulock intramedullary implant will be used to repair fibula fractures

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

Collaborators and Investigators

• Sponsor: Arthrex, Inc.
• Investigators: Principal Investigator: Terrence Philbin, MD, Orthopedic Foot & Ankle; Principal Investigator: Selene Parekh, MD, NCOC; Principal Investigator: Chris Hodgkins, MD, Baptist Health South Florida, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2016
• Primary Completion (Actual): July 9, 2020
• Study Completion (Actual): July 9, 2020

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: FIB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No