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Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique

Primary Purpose

Displaced Metatarsal Neck Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Reduction and fixation of metatarsal neck fracture by metaizeau's technique
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Displaced Metatarsal Neck Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patient with displaced fracture neck of the 2nd, 3rd or 4th metatarsal Exclusion Criteria: 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

Sites / Locations

  • Sohag universityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adult patient with displaced metatarsal head fractures

Arm Description

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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Foot and Ankle Outcome Score (FAOS)
FAOS is a questionnaire that is used to evaluate symptoms and functional limitations caused by ankle and foot alterations. The questionnaire consists of 42 items distributed into five subscales: pain (9 items), symptoms (7 items), function in daily living (17 items), function in sports and recreation (5 items) and quality of life (4 items).The score is calculated for each subscale using the following formula: 100 - (subject score multiplied by 100 divided by the maximum score possible in the subscale). Scores vary from zero to 100, where zero indicates extreme symptoms and 100 indicates absence of symptoms.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
May 19, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05640466
Brief Title
Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
Official Title
Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Displaced Metatarsal Neck Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Single intervention no masking
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult patient with displaced metatarsal head fractures
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Reduction and fixation of metatarsal neck fracture by metaizeau's technique
Intervention Description
Reduction and fixation of metatarsal neck fracture by metaizeau's technique
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time Frame
8 weeks postoperatively
Title
Foot and Ankle Outcome Score (FAOS)
Description
FAOS is a questionnaire that is used to evaluate symptoms and functional limitations caused by ankle and foot alterations. The questionnaire consists of 42 items distributed into five subscales: pain (9 items), symptoms (7 items), function in daily living (17 items), function in sports and recreation (5 items) and quality of life (4 items).The score is calculated for each subscale using the following formula: 100 - (subject score multiplied by 100 divided by the maximum score possible in the subscale). Scores vary from zero to 100, where zero indicates extreme symptoms and 100 indicates absence of symptoms.
Time Frame
8 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient with displaced fracture neck of the 2nd, 3rd or 4th metatarsal Exclusion Criteria: 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
Facility Information:
Facility Name
Sohag university
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. S. Mousa, Prof. Orthopaedics
Phone
+20932710288
Email
shazli_mousa@med.sohag.edu.eg
First Name & Middle Initial & Last Name & Degree
H. S. Mohammed, B.Sc Med

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/9724
Description
Central metatarsal fractures: a review and current concepts
URL
https://link.springer.com/article/10.4103/ortho.IJOrtho_563_17
Description
Management of Talar Body Fractures
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822033/
Description
AOFAS Functional Scoring After Antegrade K Wires Fixation of Multiple Metatarsal Neck Fracture: A Case Report

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Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique

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