Miniplate Versus k Wires in Management of Metacarpal Fracture

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

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

Study Overview

• Status: Unknown
• Conditions: Metacarpal Fracture
• Intervention / Treatment: Device: miniplate

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] .

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mina kamal, resident; Phone Number: 01203380329; Email: minakamalcr7@gmail.com
• Study Contact Backup: Name: kamal elgafary, professor; Phone Number: 01223144899; Email: Kamalelgafary@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group one; patient with metacarpal fracture that will use minipate for fixation	Device: miniplate; comparison between k wires and miniplate in metacarpal fractures; Other Names: k wires
Active Comparator: gruop two; patient with metacarpal fracture that will use buried k wires for fixation	Device: miniplate; comparison between k wires and miniplate in metacarpal fractures; Other Names: k wires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: miniplate,k wires and union

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No