Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck

NCT ID: NCT06449755

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-02-01

Brief Summary

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The goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. The main questions it aims to answer are:

* Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application?
* Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application? Patients will be followed up at the 1st week, 1st month and 3rd month postoperatively. Functionality will be evaluated with Quick DASH score at the 3rd month. At the 1st and 3rd month controls, grip strength will be evaluated. At the same time, metacarpal shortening and angulations will be measured on x-ray. Researchers will compare percutaneous screw and elastic nail group to see grip strength, healing time and radiologic parameter difference.

Detailed Description

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In this study, patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included. Exclusion criteria will include patients with other concomitant trauma, open fractures, fractures with intraarticular joint extension, and previous hand surgery in which the hand anatomy was distorted. Patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study. One of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation, while the other group will undergo intramedullary antegrade elastic nail application. Patients will be followed up with ulnar gutter splint for the first week postoperatively. After the first week, the splint will be removed and range of motion, gripping and pinching exercises will be given to the patients.

Radiological examinations (dorsal angulation and metacarpal shortening will be measured) will be performed in the first week, first and third months postoperatively. Hand grip strength will be measured with Cambry dynamometer at the first and third month. At the 3rd month, upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups.

Randomisation will be performed with an internet-based application. Clinical ethics committee approval was obtained before the study started.

Conditions

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Metacarpal Fracture Boxer's Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Elastic Nail

Percutaneous antegrade elastic nail fixation

Group Type OTHER

Radiologic examination

Intervention Type DIAGNOSTIC_TEST

Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation

Grip Strength

Intervention Type PROCEDURE

Postoperative first month and third month grip streng compare with Cambry hand dinamometer.

Quick DASH Questionnaire

Intervention Type OTHER

Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.

Screw

Percutaneous retrograde screw fixation

Group Type OTHER

Radiologic examination

Intervention Type DIAGNOSTIC_TEST

Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation

Grip Strength

Intervention Type PROCEDURE

Postoperative first month and third month grip streng compare with Cambry hand dinamometer.

Quick DASH Questionnaire

Intervention Type OTHER

Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.

Interventions

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Radiologic examination

Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation

Intervention Type DIAGNOSTIC_TEST

Grip Strength

Postoperative first month and third month grip streng compare with Cambry hand dinamometer.

Intervention Type PROCEDURE

Quick DASH Questionnaire

Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-60 years with displaced fifth metacarpal fractures with angulation greater than 30 degrees

Exclusion Criteria

* Open fracture
* Patients with multiple injuries
* History of hand surgery
* Intraarticular metacarpal neck fractures
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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AHMET MUCTEBA YILDIRIM

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serkan MD Bayram, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Istanbul Unıversity Medicine Faculty Orthopaedic Department

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ahmet Muçteba AM Yıldırım, Fellow

Role: CONTACT

+090 534 3038472

Facility Contacts

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Ahmet Muçteba AM Yıldırım, Fellow

Role: primary

+090 534 303 8472

Other Identifiers

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159108493

Identifier Type: -

Identifier Source: org_study_id

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