Fibula FractureFibulockNCT02688296
Effectiveness Of The Fibulock Intramedullary Nail
An observational study of Fibula Fracture, run by Arthrex, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibula Fracture
- What is being tested?
- Fibulock
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 May 2016to 9 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.
Who may be able to join
- 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.
Who cannot join
- Patients who are not implanted with a Sonoma Fibulock IM Nail
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NCOC
Durham, North Carolina, 27707
Baptist Health South Florida
Miami, Florida, 33146
Orthopedic Foot & Ankle Center
Westerville, Ohio, 43082
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibula Fracture
- Being tested
- Fibulock
- Medical subject headings
- Fibula Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibulockDevice
Fibulock intramedullary implant will be used to repair fibula fractures
| Study group | Role | What they receive |
|---|---|---|
| Pilon Fractures | Patients who are implanted with Fibulock and have a Pilon fracture Receives: Device: Fibulock | |
| 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 Receives: Device: Fibulock | |
| Otherwise Healthy Patients | Patients implanted with Fibulock who are healthy other than their ankle fracture Receives: Device: Fibulock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Secondary outcomes (3)
Visual Analog Scale
Patient self reported pain intensity.
Measured: 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.
Measured: 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.
Measured: 26 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start24 May 2016
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibula FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terrence Philbin, MD, Principal investigator, Orthopedic Foot & AnkleSelene Parekh, MD, Principal investigator, NCOCChris Hodgkins, MD, Principal investigator, Baptist Health South Florida, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688296
- Sponsor's protocol ID
- FIB-001
- Acronym
- Fibulock
- Status last verified
- Jan 2021
- First submitted
- 10 Feb 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures
- ClinicalTrials.gov ID
- NCT02688296
- Acronym / sponsor ID
- Fibulock / FIB-001
- Conditions
- Fibula Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2016 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilon Fractures | – | Device: FibulockPatients who are implanted with Fibulock and have a Pilon fracture |
| High Risk Patients | – | Device: FibulockPatients 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 | – | Device: FibulockPatients implanted with Fibulock who are healthy other than their ankle fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are not implanted with a Sonoma Fibulock IM Nail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibulockFibulock intramedullary implant will be used to repair fibula fractures | Device | High Risk Patients, Otherwise Healthy Patients, Pilon Fractures |
Primary outcome
Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays
Time frame: 26 weeks
Lateral and mortice view x-rays at 26 weeks
3 secondary outcomes
Visual Analog Scale
Time frame: 26 weeks and 52 weeks
SF 12
Time frame: 26 weeks and 52 weeks
Foot Function Index
Time frame: 26 weeks and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Fibula Fracture
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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Ankle Fractures, Bimalleolar Fractures
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Osteosynthesis of Fibula Fractures With a Locked Thin Plate
Osteosynthesis of Fibula Fractures With a Locked Thin Plate
Recruiting
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Ankle Fractures, Ankle Fracture - Lateral Malleolus
Enrolling by invitationPhase 4
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Stress Fracture of Tibia or Fibula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Philbin, MD principal investigator
Orthopedic Foot & Ankle
Selene Parekh, MD principal investigator
NCOC
Chris Hodgkins, MD principal investigator
Baptist Health South Florida, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibula Fracture, run by Arthrex, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.