Effectiveness Of The Fibulock Intramedullary Nail
Fibulock
The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures
1 other identifier
observational
34
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedStudy Start
First participant enrolled
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2020
CompletedJanuary 20, 2021
January 1, 2021
4.1 years
February 10, 2016
January 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Visual Analog Scale
26 weeks and 52 weeks
SF 12
26 weeks and 52 weeks
Foot Function Index
26 weeks and 52 weeks
Study Arms (3)
Pilon Fractures
Patients who are implanted with Fibulock and have a Pilon fracture
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
Otherwise Healthy Patients
Patients implanted with Fibulock who are healthy other than their ankle fracture
Interventions
Fibulock intramedullary implant will be used to repair fibula fractures
Eligibility Criteria
Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.
You may qualify if:
- 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.
You may not qualify if:
- Patients who are not implanted with a Sonoma Fibulock IM Nail
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arthrex, Inc.lead
Study Sites (3)
Baptist Health South Florida
Miami, Florida, 33146, United States
NCOC
Durham, North Carolina, 27707, United States
Orthopedic Foot & Ankle Center
Westerville, Ohio, 43082, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 23, 2016
Study Start
May 24, 2016
Primary Completion
July 9, 2020
Study Completion
July 9, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share