Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

NCT ID: NCT06210191

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Detailed Description

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The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.

There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.

There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.

Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.

Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.

Conditions

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Metacarpal Fracture Phalanx Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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union of fracture

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Group Type EXPERIMENTAL

Intramedullary headless screw fixation

Intervention Type PROCEDURE

fixation of fractures of metacarpals and phalanges by intramedullary headless screws

Interventions

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Intramedullary headless screw fixation

fixation of fractures of metacarpals and phalanges by intramedullary headless screws

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Skeletally mature patients with closed fractures of phalanges and metacarpals.
2. Patients with open type I fractures of phalanges and metacarpals.

Exclusion Criteria

1. Skeletally immature patients with open physis.
2. Patients with open type II or III fractures of phalanges or metacarpals.
3. Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelrahman Megahed Ahmed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Elsayed, professor

Role: STUDY_CHAIR

Assiut University

Waleed Riad, professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Megahed, resident

Role: CONTACT

+201007712309

Facility Contacts

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Waleed Riad, professor

Role: primary

+201142123037

Other Identifiers

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Intramedullary screw fixation

Identifier Type: -

Identifier Source: org_study_id

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