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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03170687
Other study ID # 53/2560
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2017
Est. completion date September 1, 2018

Study information

Verified date September 2018
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
short foot cast
metatarsal foot cast
short leg cast
full short leg cast

Locations

Country Name City State
Thailand Jatupon Kongtharvonskul Bangkok Select...

Sponsors (2)

Lead Sponsor Collaborator
Jatupon Kongtharvonskul Police General Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other rescue medication paracetamol or NSAIDs 8 weeks
Primary VAS visual analog score 8 weeks
Secondary AOFAS foot score 8 weeks
Secondary union rate radiographic union 8 weeks
Secondary complication skin ulcer or compartment syndrome 8 weeks