Charcot Arthropathy of HindfootNCT05717816
Hindfoot Fusion Using Intramedullary Nail in Diabetic Ankle Arthropathy
An observational study of Charcot Arthropathy of Hindfoot, run by Ehab Ahmed Mohamed.
Trial summary
The aim of this study is to evaluate the outcome of healing rate of ankle fusion using modified retrograde IM femoral nail with plate in charcot ankle Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Charcot Arthropathy of Hindfoot
- What is being tested?
- intramedullary nail and plate
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Feb 2024
- 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: All patients admitted at our trauma center at Assuit university hospital meeting the above mentioned criteria
Who may be able to join
- Adult diabetic Patients who have (Brodsky type 2 and type 3A) Charcot ankle and HbA1c below 8
Who cannot join
- Prescence of active infection
- prescence of ulcers
- significant bone defect
- Vascular insufficiency
About this study
Official title: Results of Hindfoot Fusion Using Modified Retrograde Intramedullary Femoral Nail With Plate in Diabetic Charcot Ankle Arthropathy : A Prospective Case Series Study
The aim of this study is to evaluate the outcome of healing rate of ankle fusion using modified retrograde IM femoral nail with plate in charcot ankle
Read the detailed description
Charcot neuroarthropathy, is a progressive, noninfectious, and destructive joint disorder following trauma to a neuropathic extremity.The disorder mainly occurs in the foot and ankle joints. The process consists of bone and joint destruction, joint deformity, ulceration, and, if left untreated, may lead to amputation. The majority of the Charcot joint cases are associated with a neuropathic complication in patients with diabetes. Thus, with the increase in the current incidence of diabetes, the increase of Charcot joint cases is also expected.
The treatment of Charcot joint is variable including non operative, such as total contact casting, modified shoe, medication, and operative treatment. However, when the deformity is severe and unstable, the operative management is necessary. There are some surgical approaches to manage Charcot joint, such as exostectomy, Achilles tendon lengthening, arthrodesis with internal or external fixation, and amputation.
Arthrodesis is indicated in severe Charcot joint with significant instability. For Charcot ankle arthrodesis, internal fixation is more popular than external fixation in the absence of infection, significant bone defect, and poor soft tissue coverage. Some of the methods of internal fixation for ankle arthrodesis include the use of retrograde intramedullary nails, screws, and plates. many surgeons chose retrograde intramedullary nail fixation as the main method of internal fixation. However, limited compression and high nonunion rates have been found with intramedullary nail fixation.so using Plate with intramedullary nail will offer stiff constructs, more stability and better union rates. however, studies evaluating the use of combination fixation in the ankle arthrodesis for Charcot ankle, particularly nail with plate, are limited. [13] So, in this study the investigators will evaluate the outcomes of ankle arthrodesis using a combination of an intramedullary nail with plate in patients with diabetic Charcot ankle.
- Conditions
- Charcot Arthropathy of Hindfoot
- Being tested
- intramedullary nail and plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nail and plateDevice
fusing Charcot ankle using retrograde intrameudllary femoral nail and plate
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological fusion
fusion of the Charcot ankle assessed by X- ray
Measured: to be assessed up to one year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot Arthropathy of HindfootStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ehab Ahmed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ehab Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717816
- Sponsor's protocol ID
- HFFIMN
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Hindfoot Fusion Using Modified Retrograde Intramedullary Femoral Nail With Plate in Diabetic Charcot Ankle Arthropathy : A Prospective Case Series Study
- ClinicalTrials.gov ID
- NCT05717816
- Acronym / sponsor ID
- HFFIMN
- Conditions
- Charcot Arthropathy of Hindfoot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ehab Ahmed MohamedUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
The aim of this study is to evaluate the outcome of healing rate of ankle fusion using modified retrograde IM femoral nail with plate in charcot ankle
Detailed description
Charcot neuroarthropathy, is a progressive, noninfectious, and destructive joint disorder following trauma to a neuropathic extremity.The disorder mainly occurs in the foot and ankle joints. The process consists of bone and joint destruction, joint deformity, ulceration, and, if left untreated, may lead to amputation. The majority of the Charcot joint cases are associated with a neuropathic complication in patients with diabetes. Thus, with the increase in the current incidence of diabetes, the increase of Charcot joint cases is also expected.
The treatment of Charcot joint is variable including non operative, such as total contact casting, modified shoe, medication, and operative treatment. However, when the deformity is severe and unstable, the operative management is necessary. There are some surgical approaches to manage Charcot joint, such as exostectomy, Achilles tendon lengthening, arthrodesis with internal or external fixation, and amputation.
Arthrodesis is indicated in severe Charcot joint with significant instability. For Charcot ankle arthrodesis, internal fixation is more popular than external fixation in the absence of infection, significant bone defect, and poor soft tissue coverage. Some of the methods of internal fixation for ankle arthrodesis include the use of retrograde intramedullary nails, screws, and plates. many surgeons chose retrograde intramedullary nail fixation as the main method of internal fixation. However, limited compression and high nonunion rates have been found with intramedullary nail fixation.so using Plate with intramedullary nail will offer stiff constructs, more stability and better union rates. however, studies evaluating the use of combination fixation in the ankle arthrodesis for Charcot ankle, particularly nail with plate, are limited. [13] So, in this study the investigators will evaluate the outcomes of ankle arthrodesis using a combination of an intramedullary nail with plate in patients with diabetic Charcot ankle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted at our trauma center at Assuit university hospital meeting the above mentioned criteria
Key inclusion criteria (1 listed)
- Adult diabetic Patients who have (Brodsky type 2 and type 3A) Charcot ankle and HbA1c below 8
Key exclusion criteria (4 listed)
- Prescence of active infection
- prescence of ulcers
- significant bone defect
- Vascular insufficiency
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 |
|---|---|---|
| intramedullary nail and platefusing Charcot ankle using retrograde intrameudllary femoral nail and plate | Device | – |
Primary outcome
Radiological fusion
Time frame: to be assessed up to one year post operative
fusion of the Charcot ankle assessed by X- ray
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Charcot Arthropathy of Hindfoot, run by Ehab Ahmed Mohamed.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Radiological fusion (time frame: to be assessed up to one year post operative). 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 8 Feb 2023.