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

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

Study Overview

• Status: Completed
• Conditions: Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
• Intervention / Treatment: Device: short foot cast; Device: short leg cast

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Select...
    • Bangkok, Select..., Thailand, 10400
      • Jatupon Kongtharvonskul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:acute closed fracture of proximal fifth metatarsal (zone II) with following 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: foot cast	Device: short foot cast; metatarsal foot cast
ACTIVE_COMPARATOR: short leg cast	Device: short leg cast; full short leg cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	visual analog score	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS	foot score	8 weeks
union rate	radiographic union	8 weeks
complication	skin ulcer or compartment syndrome	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
rescue medication	paracetamol or NSAIDs	8 weeks

Collaborators and Investigators

• Sponsor: Jatupon Kongtharvonskul
• Collaborators: Police General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2017
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Closed; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 53/2560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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