ClinicalTrials.gg
CompletedNCT03170687Updated Sep 18, 2018

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

An interventional study of short foot cast and short leg cast in Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II), sponsored by Jatupon Kongtharvonskul. Completed at 1 site in Thailand. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Jatupon Kongtharvonskul · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2017, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

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03

In context

Fractures, Closed

44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.

This study's enrollment of 72 is above the median of 45 across 34 interventional studies indexed under Fractures, Closed.

Browse Fractures, Closed studies →

Lead sponsor

This is the only study on the registry with Jatupon Kongtharvonskul as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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. refuse to inform consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    foot cast

    Device: short foot cast

  • Active comparator
    short leg cast

    Device: short leg cast

Interventions

  • Deviceshort foot cast

    metatarsal foot cast

  • Deviceshort leg cast

    full short leg cast

06

What researchers measure

Primary outcomes

  1. VAS

    visual analog score

    Time frame: 8 weeks

Secondary outcomes

  1. AOFAS

    foot score

    Time frame: 8 weeks

  2. union rate

    radiographic union

    Time frame: 8 weeks

  3. complication

    skin ulcer or compartment syndrome

    Time frame: 8 weeks

Other outcomes

  1. rescue medication

    paracetamol or NSAIDs

    Time frame: 8 weeks

07

Study locations

1 site
  • Jatupon Kongtharvonskul
    Bangkok, Select... 10400, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Sep 2018, 19 months.

Of 14 interventional studies with no phase under Fractures, Closed, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 49. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2017
First posted
May 31, 2017
StartActual
Jan 24, 2017
Primary completionActual
Sep 1, 2018
CompletionActual
Sep 1, 2018
Last update
Sep 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03170687
Lead sponsor
Jatupon Kongtharvonskul
Collaborators
Police General Hospital
Responsible party
Jatupon Kongtharvonskul (clinical doctor in section of clinical epidermiology and biostatistic, Ramathibodi Hospital) — Sponsor-investigator
First posted
May 31, 2017
Start date
Jan 24, 2017
Primary completion
Sep 1, 2018
Completion
Sep 1, 2018
Last update
Sep 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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