Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

NCT ID: NCT03170687

Last Updated: 2018-09-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2018-09-01

Brief Summary

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This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).

Detailed Description

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A randomized controlled trial will conducts between January 2017 and January 2019, participants with acute fifth metatarsal fracture (Zone II) will recruit for this study at the orthopedic outpatient clinic of a police general hospital, Bangkok, Thailand. A total of 100 patients will randomly allocate to receive foot cast or short leg cast. acute closed fracture of proximal fifth metatarsal (zone II) patients.

Conditions

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Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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foot cast

Group Type EXPERIMENTAL

short foot cast

Intervention Type DEVICE

metatarsal foot cast

short leg cast

Group Type ACTIVE_COMPARATOR

short leg cast

Intervention Type DEVICE

full short leg cast

Interventions

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short foot cast

metatarsal foot cast

Intervention Type DEVICE

short leg cast

full short leg cast

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. History of trauma and pain at lateral side of foot
2. Tenderness at base of 5th metatarsal
3. Radiographic finding shown fracture line at proximal 5th metatarsal bone

Exclusion Criteria

1. more than 1 week
2. comminuted or multiple fracture
3. Open fracture
4. Ligament and tendon injury
5. Previous injury complication: nonunion, delayed union
6. Malignancy
7. refuse to inform consent
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Police General Hospital

OTHER

Sponsor Role collaborator

Jatupon Kongtharvonskul

OTHER

Sponsor Role lead

Responsible Party

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Jatupon Kongtharvonskul

clinical doctor in section of clinical epidermiology and biostatistic

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jatupon Kongtharvonskul

Bangkok, Select..., Thailand

Site Status

Countries

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Thailand

Other Identifiers

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53/2560

Identifier Type: -

Identifier Source: org_study_id

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