Clinical trial NCT02688296: Effectiveness Of The Fibulock Intramedullary Nail
Official title: The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibula Fracture
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays
timeFrame: 26 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 26 weeks and 52 weeks
measure: SF 12
timeFrame: 26 weeks and 52 weeks
measure: Foot Function Index
timeFrame: 26 weeks and 52 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Durham
country: United States
facility: NCOC
state: North Carolina
city: Westerville
country: United States
facility: Orthopedic Foot & Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot & Ankle
name: Terrence Philbin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCOC
name: Selene Parekh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Health South Florida, Inc.
name: Chris Hodgkins, MD
role: PRINCIPAL_INVESTIGATOR
References: