Effectiveness Of The Fibulock Intramedullary Nail

Arthrex

Status: Completed

Conditions: Fibula Fracture

Treatments: Device: Fibulock

Study type: Observational

Funder types: Industry

Identifiers

NCT02688296

FIB-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 3 patient groups

Pilon Fractures

Description:

Patients who are implanted with Fibulock and have a Pilon fracture

Treatment:

Device: Fibulock

High Risk Patients

Description:

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

Treatment:

Device: Fibulock

Otherwise Healthy Patients

Description:

Patients implanted with Fibulock who are healthy other than their ankle fracture

Treatment:

Device: Fibulock