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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05640466
Collaborator
(none)
20
1
1
12
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Single intervention no masking
Primary Purpose:
Treatment
Official Title:
Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Adult patient with displaced metatarsal head fractures

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.

Device: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
Reduction and fixation of metatarsal neck fracture by metaizeau's technique

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) [8 weeks postoperatively]

    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').

  2. Foot and Ankle Outcome Score (FAOS) [8 weeks post-operatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Sohag Egypt 82511

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hussien Sedik Mohamed, Orthopedic Surgery Resident, Sohag University
ClinicalTrials.gov Identifier:
NCT05640466
Other Study ID Numbers:
  • Sohagu1
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2022