NCT03170687

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

May 25, 2017

Last Update Submit

September 16, 2018

Conditions

Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

Outcome Measures

Primary Outcomes (1)

  • VAS

    visual analog score

    8 weeks

Secondary Outcomes (3)

  • AOFAS

    8 weeks

  • union rate

    8 weeks

  • complication

    8 weeks

Other Outcomes (1)

  • rescue medication

    8 weeks

Study Arms (2)

foot cast

EXPERIMENTAL
Device: short foot cast

short leg cast

ACTIVE COMPARATOR
Device: short leg cast

Interventions

short foot castDEVICE

metatarsal foot cast

foot cast
short leg castDEVICE

full short leg cast

short leg cast

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • more than 1 week
  • comminuted or multiple fracture
  • Open fracture
  • Ligament and tendon injury
  • Previous injury complication: nonunion, delayed union
  • Malignancy
  • refuse to inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jatupon Kongtharvonskul

Bangkok, Select..., 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical doctor in section of clinical epidermiology and biostatistic

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 31, 2017

Study Start

January 24, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)