Ankle FracturesNCT05204485
Diabetic Fibular Nail Study
A study testing Fibular intramedullary nail and Open reduction and internal fixation in people with Ankle Fractures, run by University of Chicago at 1 site in United States.
Trial summary
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Fibular intramedullary nail and Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 19 Jan 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Unstable ankle fracture
- Diagnosis of Diabetes:
- Fasting BG > 120
- Non-fasting BG > 200
- HbA1c > 6.5
Who cannot join
- Patients not meeting inclusion criteria (stable fracture patterns, non-diabetics)
- Poly-trauma patients (multiple [>2] extremity injuries that interfere and/or limit patient mobilization
- Open fractures
- Delayed presentation of fracture (>4 weeks)
- Fractures that the treating surgeon indicates requires a posterior approach to achieve stability
- Patients with an active infection or wound at the ankle
Show all 12Show fewer
- Utilizing worker's compensation at the time of screening
- Any previous ligament or fracture surgery on the index ankle
- Inflammatory rheumatic disease or other rheumatic disease
- Immune compromised patients (hepatitis, HIV, etc.)
- Non-English speaking patients
- Unwilling or unable to follow study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized-Control Trial Comparing Intramedullary Fibular Fixation With Standard Open Reduction And Internal Fixation In Diabetic Patients With Unstable Ankle Fracture
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
Read the detailed description
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
With much of the existing literature on fibular nails being retrospective with limited focus on the diabetic population, there is no clear guidance on when the use of this device is indicated. Retrospective studies in fracture patients bring in significant bias given that a specific surgical technique may be chosen because of individual patient factors including soft tissue condition, fracture pattern and perceived level of risk. This limits our understanding of how an implant will perform across the population of interest. Our approach to randomize our patients will reduce the bias that exists in the current literature. In addition, the only prospective study that has been performed on the fibular nail was in elderly patients in which only two patients were diabetic. Given the many challenges with high rates of infection in this patient population we seek intramedullary fibular fracture fixation as a treatment that could potentially change this existing paradigm
Primary Objective Compare post-operative all cause complications in diabetic patients with ankle fractures.
Secondary Objective(s) Compare patient reported outcomes, range of motion, pain and radiographic outcomes in patients treated with ORIF vs. fibular intramedullary nails.
- Conditions
- Ankle Fractures
- Being tested
- Fibular intramedullary nail, Open reduction and internal fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibular intramedullary nailProcedure or surgery
The standard manufacturers approved technique will be performed including the use of 2 distal interlocking screws and the use of a minimum of 1 fibula pro tibia fixation screw depending on the patients' anatomical characteristics.
Open reduction and internal fixationProcedure or surgery
An open approach (direct lateral or posterolateral incision) will be carried out. The reduction will be performed using standard techniques of clamping and traction. Fixation will be performed after reduction of the fracture with a plate and screw construct. The surgeon will then proceed to perform surgical fixation of other associated fractures or ligament injuries as indicated. This will most often include open reduction and internal fixation of the medial malleolus with screws through a separate medial incision.
| Study group | Role | What they receive |
|---|---|---|
| Fibular intramedullary nail | Active comparator | Randomized in the OR to ankle fracture repair with fibular intramedullary nail Receives: Procedure: Fibular intramedullary nail |
| Open reduction and internal fixation (ORIF) | Active comparator | Randomized in the OR to ankle fracture repair with ORIF Receives: Procedure: Open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complication rate
The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF
Measured: 1 year post-operatively
Secondary outcomes (1)
Patient reported outcome scores
Any difference in Patient reported outcomes scores (PROMIS Physical Function or Pain Interference CAT) score between Fibular Intramedullary fixation and ORIF
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Mar 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Why it stopped: Low enrollment making completion of the study impossible, relocation of both the PI and Co-PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Hynes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204485
- Sponsor's protocol ID
- IRB21-1218
- Status last verified
- Oct 2024
- First submitted
- 12 Jan 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized-Control Trial Comparing Intramedullary Fibular Fixation With Standard Open Reduction And Internal Fixation In Diabetic Patients With Unstable Ankle Fracture
- ClinicalTrials.gov ID
- NCT05204485
- Acronym / sponsor ID
- IRB21-1218
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment making completion of the study impossible, relocation of both the PI and Co-PI
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- 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.
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
Detailed description
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
With much of the existing literature on fibular nails being retrospective with limited focus on the diabetic population, there is no clear guidance on when the use of this device is indicated. Retrospective studies in fracture patients bring in significant bias given that a specific surgical technique may be chosen because of individual patient factors including soft tissue condition, fracture pattern and perceived level of risk. This limits our understanding of how an implant will perform across the population of interest. Our approach to randomize our patients will reduce the bias that exists in the current literature. In addition, the only prospective study that has been performed on the fibular nail was in elderly patients in which only two patients were diabetic. Given the many challenges with high rates of infection in this patient population we seek intramedullary fibular fracture fixation as a treatment that could potentially change this existing paradigm
Primary Objective Compare post-operative all cause complications in diabetic patients with ankle fractures.
Secondary Objective(s) Compare patient reported outcomes, range of motion, pain and radiographic outcomes in patients treated with ORIF vs. fibular intramedullary nails.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibular intramedullary nail | Active comparator | Procedure: Fibular intramedullary nailRandomized in the OR to ankle fracture repair with fibular intramedullary nail |
| Open reduction and internal fixation (ORIF) | Active comparator | Procedure: Open reduction and internal fixationRandomized in the OR to ankle fracture repair with ORIF |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Unstable ankle fracture
- Diagnosis of Diabetes:
Key exclusion criteria (12 listed)
- Patients not meeting inclusion criteria (stable fracture patterns, non-diabetics)
- Poly-trauma patients (multiple [>2] extremity injuries that interfere and/or limit patient mobilization
- Open fractures
- Delayed presentation of fracture (>4 weeks)
- Fractures that the treating surgeon indicates requires a posterior approach to achieve stability
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 |
|---|---|---|
| Fibular intramedullary nailThe standard manufacturers approved technique will be performed including the use of 2 distal interlocking screws and the use of a minimum of 1 fibula pro tibia fixation screw depending on the patients' anatomical characteristics. | Procedure or surgery | Fibular intramedullary nail |
| Open reduction and internal fixationAn open approach (direct lateral or posterolateral incision) will be carried out. The reduction will be performed using standard techniques of clamping and traction. Fixation will be performed after reduction of the fracture with a plate and screw construct. The surgeon will then proceed to perform surgical fixation of other associated fractures or ligament injuries as indicated. This will most often include open reduction and internal fixation of the medial malleolus with screws through a separate medial incision. | Procedure or surgery | Open reduction and internal fixation (ORIF) |
Primary outcome
Composite complication rate
Time frame: 1 year post-operatively
The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF
1 secondary outcome
Patient reported outcome scores
Time frame: 1 year post-operatively
Results and safety
The study was stopped early (reason given: Low enrollment making completion of the study impossible, relocation of both the PI and Co-PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Kelly Hynes, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibular intramedullary nail and Open reduction and internal fixation in people with Ankle Fractures, run by University of Chicago at 1 site 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 12 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: stopped early, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Low enrollment making completion of the study impossible, relocation of both the PI and Co-PI). Results are not available in the source record.
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?
Composite complication rate (time frame: 1 year post-operatively). 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 16 Oct 2024.