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An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone

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: NCT01592604
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : August 26, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common fractures in the foot, frequently treated in fracture clinics and involving significant resources. At present methods of treatment and follow up vary widely from no active treatment to surgery, depending entirely on a treating doctor preference. There is no agreement on simple, safe and reliable method of treatment. The investigators believe that vast majority of these injuries heal well on its own without any specific treatment. By comparing two most commonly used treatments the investigators aim to establish one simple, safe and reliable mode of treatments. The investigators are going to evaluate functional results of these two treatments in a short and longer time prospective, by using the best available scientific tools. The investigators believe that results of the investigators study will eventually lead to change of practise and more efficient NHS care for these patients. It will reduce unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a long prospective.

Condition or disease Intervention/treatment
Closed Fracture of Base of Fifth Metatarsal Bone Device: Compressive bandage Device: Below knee walking cast

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone. A Level I Prospective Randomised Control Trial
Study Start Date : November 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment A
Patients receive supportive compressive bandage for 4 weeks
Device: Compressive bandage
Compressive below knee bandage for 4 weeks in group A
Experimental: Treatment B
Below knee walking plaster cast for 4 weeks
Device: Below knee walking cast
Below knee walking cast for 4 weeks

Outcome Measures

Primary Outcome Measures :
  1. Validated Visual analague scale for foot and ankle (VAS FA) score [ Time Frame: 6 months post treatment ]
    To evaluate functional outcome 6 months post treatment

Secondary Outcome Measures :
  1. Euroqol 5D [ Time Frame: baseline, 4 weeks, 3 months, 6 months post treatment ]
    Standardised general health functional outcome measure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients (older than 15 years of age) with an acute closed isolated type I avulsion fractures of the base of the fifth metatarsal bone, (within 7 days of the injury)

Exclusion Criteria:

  • Diabetes, Inflammatory arthritis, previous same foot tarso-metatarsal fractures, previous same foot surgery, more than 7 days since the injury.
Contacts and Locations

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): NCT01592604

United Kingdom
Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Pavel - Akimau, MBChB Sheffield Teaching Hopsitals
More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01592604     History of Changes
Other Study ID Numbers: STH 15761
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
fifth metatarsal
functioanl outcome

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Fractures, Avulsion
Wounds and Injuries