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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01592604
First received: April 5, 2012
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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 Intervention
Closed Fracture of Base of Fifth Metatarsal Bone
Device: Compressive bandage
Device: Below knee walking cast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Validated Visual analague scale for foot and ankle (VAS FA) score [ Time Frame: 6 months post treatment ] [ Designated as safety issue: Yes ]
    To evaluate functional outcome 6 months post treatment


Secondary Outcome Measures:
  • Euroqol 5D [ Time Frame: baseline, 4 weeks, 3 months, 6 months post treatment ] [ Designated as safety issue: Yes ]
    Standardised general health functional outcome measure


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592604

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

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01592604     History of Changes
Other Study ID Numbers: STH 15761
Study First Received: April 5, 2012
Last Updated: August 23, 2013
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on November 25, 2014