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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

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)
03

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. Malignancy
  7. refuse to inform consent
04

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

05

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

06

Study locations

1 site
  • Jatupon Kongtharvonskul
    Bangkok, Select... 10400, Thailand
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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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