Miniplate Versus k Wires in Management of Metacarpal Fracture
Primary Purpose
Metacarpal Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
miniplate
Sponsored by
About this trial
This is an interventional treatment trial for Metacarpal Fracture
Eligibility Criteria
Inclusion Criteria:
- Age: ( 20-60) years,
- Fresh (fixed within 3 days),
- Single or multiple fractures of metacarpals.
Exclusion Criteria:
- Pathological fracture,
- Major systemic illness, malignancy,
- Patient on drugs affecting fracture healing like steroid, anticancer drugs,
- Polytrauma patients,
- Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
- Dislocations at either end of the fractured bone
- Parents/guardians/patients not willing to participate in study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group one
gruop two
Arm Description
patient with metacarpal fracture that will use minipate for fixation
patient with metacarpal fracture that will use buried k wires for fixation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04605341
Brief Title
Miniplate Versus k Wires in Management of Metacarpal Fracture
Official Title
Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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] .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metacarpal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group one
Arm Type
Active Comparator
Arm Description
patient with metacarpal fracture that will use minipate for fixation
Arm Title
gruop two
Arm Type
Active Comparator
Arm Description
patient with metacarpal fracture that will use buried k wires for fixation
Intervention Type
Device
Intervention Name(s)
miniplate
Other Intervention Name(s)
k wires
Intervention Description
comparison between k wires and miniplate in metacarpal fractures
Primary Outcome Measure Information:
Title
miniplate,buried k wires and union
Description
• 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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Range of motion
Description
• Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: ( 20-60) years,
Fresh (fixed within 3 days),
Single or multiple fractures of metacarpals.
Exclusion Criteria:
Pathological fracture,
Major systemic illness, malignancy,
Patient on drugs affecting fracture healing like steroid, anticancer drugs,
Polytrauma patients,
Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
Dislocations at either end of the fractured bone
Parents/guardians/patients not willing to participate in study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mina kamal, resident
Phone
01203380329
Email
minakamalcr7@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
kamal elgafary, professor
Phone
01223144899
Email
Kamalelgafary@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Miniplate Versus k Wires in Management of Metacarpal Fracture
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