Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03170687
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Police General Hospital
Information provided by (Responsible Party):
Jatupon Kongtharvonskul, Ramathibodi Hospital

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

Condition or disease Intervention/treatment Phase
Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II) Device: short foot cast Device: short leg cast Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
Actual Study Start Date : January 24, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: foot cast Device: short foot cast
metatarsal foot cast

Active Comparator: short leg cast Device: short leg cast
full short leg cast




Primary Outcome Measures :
  1. VAS [ Time Frame: 8 weeks ]
    visual analog score


Secondary Outcome Measures :
  1. AOFAS [ Time Frame: 8 weeks ]
    foot score

  2. union rate [ Time Frame: 8 weeks ]
    radiographic union

  3. complication [ Time Frame: 8 weeks ]
    skin ulcer or compartment syndrome


Other Outcome Measures:
  1. rescue medication [ Time Frame: 8 weeks ]
    paracetamol or NSAIDs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170687


Locations
Layout table for location information
Thailand
Jatupon Kongtharvonskul
Bangkok, Select..., Thailand, 10400
Sponsors and Collaborators
Jatupon Kongtharvonskul
Police General Hospital

Layout table for additonal information
Responsible Party: Jatupon Kongtharvonskul, clinical doctor in section of clinical epidermiology and biostatistic, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT03170687     History of Changes
Other Study ID Numbers: 53/2560
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Fractures, Closed
Wounds and Injuries
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action