Displaced Metatarsal Neck FractureNCT05640466
Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
A study testing Reduction and fixation of metatarsal neck fracture by metaizeau's technique in people with Displaced Metatarsal Neck Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year. The goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Displaced Metatarsal Neck Fracture
- What is being tested?
- Reduction and fixation of metatarsal neck fracture by metaizeau's technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 11 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Adult patient with displaced fracture neck of the 2nd, 3rd or 4th metatarsal
Who cannot join
- Poly_traumatized patient .
- Patient with fracture first and fifth metatarsal bone .
- Fracture shaft metatarsal bone , first MB, fifth MB.
- Open fractures of the foot .
- Intraarticular fracture of metatarsals .
- Lisfranc fracture .
- Segmental fracture of the metatarsals
Trial locations and contacts
1 site in 1 country.
About this study
Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.
The goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment.
Metaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site.
Read the detailed description
Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.
Metatarsal fractures have been considered of little importance by many authors over the years, and have received little attention. That is why little literature about operative management of metatarsal fractures can be found (apart from the first and fifth metatarsal bones).
Generally, these are non-displaced fractures. When these fractures show some displacement, reasonable alignment must be obtained because the metatarsals' capability for remodelling is extensive but not infinite.
Displaced metatarsal neck fractures are usually treated by means of retrograde Kirschner wires, which generally requires an open reduction at the fracture site due to the difficulty of reducing the metatarsal head.
Metaizeau's technique can be applied to reduce the displaced metatarsal head distally from the fracture in an easier way and to keep the fracture site closed, as compared with retrograde Kirschner wires method . Open reduction was unnecessary in all cases. This technique permitted correct control of the distal fracture fragment, obtained good reduction of the metatarsal heads without opening the fracture site, and with no lesion of the capsuloligamentous complex of metatarsophalangeal joint. Metaizeau's technique is a valid alternative to retrograde method.
The goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment. Metaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site.
- Conditions
- Displaced Metatarsal Neck Fracture
- Being tested
- Reduction and fixation of metatarsal neck fracture by metaizeau's technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction and fixation of metatarsal neck fracture by metaizeau's techniqueDevice
Reduction and fixation of metatarsal neck fracture by metaizeau's technique
| Study group | Role | What they receive |
|---|---|---|
| Adult patient with displaced metatarsal head fractures | Other | A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire. Receives: Device: Reduction and fixation of metatarsal neck fracture by metaizeau's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Union
Time taken from operation till full fracture union
Measured: 8 weeks postoperatively
Time to Range of Motion (ROM) Start
Time taken from operation till starting range of motion (ROM)
Measured: 8 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Oct 2022
- Primary completion1 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Displaced Metatarsal Neck FractureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussien Sedik Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640466
- Sponsor's protocol ID
- Sohagu1
- Status last verified
- Jul 2023
- First submitted
- 22 Nov 2022
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
- ClinicalTrials.gov ID
- NCT05640466
- Acronym / sponsor ID
- Sohagu1
- Conditions
- Displaced Metatarsal Neck Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Posted 23 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.
The goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment.
Metaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site.
Detailed description
Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.
Metatarsal fractures have been considered of little importance by many authors over the years, and have received little attention. That is why little literature about operative management of metatarsal fractures can be found (apart from the first and fifth metatarsal bones).
Generally, these are non-displaced fractures. When these fractures show some displacement, reasonable alignment must be obtained because the metatarsals' capability for remodelling is extensive but not infinite.
Displaced metatarsal neck fractures are usually treated by means of retrograde Kirschner wires, which generally requires an open reduction at the fracture site due to the difficulty of reducing the metatarsal head.
Metaizeau's technique can be applied to reduce the displaced metatarsal head distally from the fracture in an easier way and to keep the fracture site closed, as compared with retrograde Kirschner wires method . Open reduction was unnecessary in all cases. This technique permitted correct control of the distal fracture fragment, obtained good reduction of the metatarsal heads without opening the fracture site, and with no lesion of the capsuloligamentous complex of metatarsophalangeal joint. Metaizeau's technique is a valid alternative to retrograde method.
The goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment. Metaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient with displaced metatarsal head fractures | Other | Device: Reduction and fixation of metatarsal neck fracture by metaizeau's techniqueA Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier. Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient with displaced fracture neck of the 2nd, 3rd or 4th metatarsal
Key exclusion criteria (7 listed)
- Poly_traumatized patient .
- Patient with fracture first and fifth metatarsal bone .
- Fracture shaft metatarsal bone , first MB, fifth MB.
- Open fractures of the foot .
- Intraarticular fracture of metatarsals .
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 |
|---|---|---|
| Reduction and fixation of metatarsal neck fracture by metaizeau's techniqueReduction and fixation of metatarsal neck fracture by metaizeau's technique | Device | Adult patient with displaced metatarsal head fractures |
Primary outcome
Time of Union
Time frame: 8 weeks postoperatively
Time taken from operation till full fracture union
Time to Range of Motion (ROM) Start
Time frame: 8 weeks post-operatively
Time taken from operation till starting range of motion (ROM)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Central metatarsal fractures: a review and current conceptsLink provided by the sponsor.
- Management of Talar Body FracturesLink provided by the sponsor.
- AOFAS Functional Scoring After Antegrade K Wires Fixation of Multiple Metatarsal Neck Fracture: A Case ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction and fixation of metatarsal neck fracture by metaizeau's technique in people with Displaced Metatarsal Neck Fracture, run by Sohag University at 1 site in Egypt.
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 7 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 23 Feb 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 Egypt. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time of Union (time frame: 8 weeks postoperatively). The study lists 2 primary outcomes in all. 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 23 Feb 2024.