Effectiveness Of The Fibulock Intramedullary Nail

Fibula Fracture Clinical Trial

— Fibulock  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688296
• Other study ID #: FIB-001
• Status: Completed
• Start date: May 24, 2016
• Est. completion date: July 9, 2020

Study information

• Verified date: January 2021
• Source: Arthrex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibula Fracture
• Fractures, Bone

Intervention

Device:
• Fibulock
Fibulock intramedullary implant will be used to repair fibula fractures

Locations

Country	Name	City	State
United States	NCOC	Durham	North Carolina
United States	Baptist Health South Florida	Miami	Florida
United States	Orthopedic Foot & Ankle Center	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale	Patient self reported pain intensity.	26 weeks and 52 weeks
Secondary	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
Secondary	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