Miniplate Versus k Wires in Management of Metacarpal Fracture

NCT ID: NCT04605341

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

Brief Summary

To compare between buried k wires and miniplate in management of metacarpal fracture.

Detailed Description

Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones [1]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) [2], which usually results from a direct blow to the metacarpal head [3]. Most hand fractures are caused by accidental falls or other sports-related injuries [4]. Hand fractures are among the most common fractures of upper extremity [5, 6]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization [7]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction [8]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation [9]. Open reduction may result in scarring, joint stiffness and tendon adhesion [7]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures [10]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization [8] .

Conditions

Metacarpal Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group one

patient with metacarpal fracture that will use minipate for fixation

Group Type: ACTIVE_COMPARATOR

miniplate

Intervention Type: DEVICE

comparison between k wires and miniplate in metacarpal fractures

gruop two

patient with metacarpal fracture that will use buried k wires for fixation

Group Type: ACTIVE_COMPARATOR

miniplate

Intervention Type: DEVICE

comparison between k wires and miniplate in metacarpal fractures

Interventions

miniplate

comparison between k wires and miniplate in metacarpal fractures

Intervention Type: DEVICE

Other Intervention Names

k wires

Eligibility Criteria

Inclusion Criteria

1. Age: ( 20-60) years,

2. Fresh (fixed within 3 days),

3. Single or multiple fractures of metacarpals.

Exclusion Criteria

1. Pathological fracture,

2. Major systemic illness, malignancy,

3. Patient on drugs affecting fracture healing like steroid, anticancer drugs,

4. Polytrauma patients,

5. Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,

6. Dislocations at either end of the fractured bone

7. Parents/guardians/patients not willing to participate in study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mina kamal

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mina kamal, resident

Role: CONTACT

minakamalcr7@gmail.com

01203380329

kamal elgafary, professor

Role: CONTACT

Kamalelgafary@yahoo.com

01223144899

Other Identifiers

miniplate,k wires and union

Identifier Type: -

Identifier Source: org_study_id