Miniplate Versus k Wires in Management of Metacarpal Fracture

NCT04605341 — Not applicable, Unknown, 50 participants, Assiut University

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

Registry	NCT04605341
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	50 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Metacarpal Fracture
Interventions	miniplate (Device)
Dates	start 2021-01-01 (estimated), primary completion 2022-11-30 (estimated), completion 2022-12-31 (estimated), first posted 2020-10-28, last updated 2020-10-28

-Summary

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

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+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 \[8\] .

+Arms and interventions

Arm	Type	Interventions	Description
group one	Active comparator	Device: miniplate	patient with metacarpal fracture that will use minipate for fixation
gruop two	Active comparator	Device: miniplate	patient with metacarpal fracture that will use buried k wires for fixation

miniplate (Device), also known as k wires: comparison between k wires and miniplate in metacarpal fractures

+Outcome measures

Primary outcomes

miniplate,buried k wires and union [6 month]: • 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 outcomes

Range of motion [6 month]: • Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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.

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