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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03170687
Date of registration: 25/05/2017
Prospective Registration: No
Primary sponsor: Jatupon Kongtharvonskul
Public title: Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Scientific title: Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Date of first enrolment: January 24, 2017
Target sample size: 72
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03170687
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Thailand
Contacts
Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Intervention(s)
Device: short foot cast
Device: short leg cast
Primary Outcome(s)
VAS [Time Frame: 8 weeks]
Secondary Outcome(s)
AOFAS [Time Frame: 8 weeks]
complication [Time Frame: 8 weeks]
union rate [Time Frame: 8 weeks]
Secondary ID(s)
53/2560
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Police General Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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