Miniplate Versus k Wires in Management of Metacarpal Fracture

Metacarpal Fracture Clinical Trial

Official title:

Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04605341
• Other study ID #: miniplate,k wires and union
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: mina kamal, resident
• Phone: 01203380329
• Email: minakamalcr7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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] .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Metacarpal Fracture

Intervention

Device:
• miniplate
comparison between k wires and miniplate in metacarpal fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miniplate,buried k wires and union	• To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices	6 month
Secondary	Range of motion	• Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.	6 month