Back to resultsComparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Primary Purpose
Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
short foot cast
short leg cast
Sponsored by
About this trial
This is an interventional treatment trial for Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Eligibility Criteria
Inclusion Criteria:acute closed fracture of proximal fifth metatarsal (zone II) with following criteria
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Jatupon Kongtharvonskul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
foot cast
short leg cast
Arm Description
Outcomes
Primary Outcome Measures
VAS
visual analog score
Secondary Outcome Measures
AOFAS
foot score
union rate
radiographic union
complication
skin ulcer or compartment syndrome
Full Information
NCT ID
NCT03170687
First Posted
May 25, 2017
Last Updated
September 16, 2018
Sponsor
Jatupon Kongtharvonskul
Collaborators
Police General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03170687
Brief Title
Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Official Title
Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jatupon Kongtharvonskul
Collaborators
Police General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
foot cast
Arm Type
Experimental
Arm Title
short leg cast
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
short foot cast
Intervention Description
metatarsal foot cast
Intervention Type
Device
Intervention Name(s)
short leg cast
Intervention Description
full short leg cast
Primary Outcome Measure Information:
Title
VAS
Description
visual analog score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
AOFAS
Description
foot score
Time Frame
8 weeks
Title
union rate
Description
radiographic union
Time Frame
8 weeks
Title
complication
Description
skin ulcer or compartment syndrome
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
rescue medication
Description
paracetamol or NSAIDs
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:acute closed fracture of proximal fifth metatarsal (zone II) with following criteria
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Jatupon Kongtharvonskul
City
Bangkok
State/Province
Select...
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
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