Clinical Trial: Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Brief Summary: This study will determine whether operative management confers improved short and long−term outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with non−operative management.

Detailed Summary:

Background:

Ankle fractures are common. Recent clinical studies have shown that there is an increasing incidence of ankle fractures. Treatments vary and there is no clear consensus of the ideal approach to type 44−B1 distal fibular fractures. They range from open reduction and internal fixation to restore anatomical alignment to wearing below−knee walking plaster for an average of six weeks.

The argument for surgical fixation is that it addresses minor displacement and possible future displacement therefore potentially preventing future arthritis. On the other hand, there are numerous complications associated with surgery.

The argument for non−operative treatment is that non−union is not a common complication. Therefore surgery can be avoided in the majority of cases avoiding the clinical risks associated with surgery.

Aim:

Primary aim: To compare, ankle function and quality of life in the 12 months following an isolated AO type 44−B1 distal fibula fracture minimal talar shift, between patients treated operatively and non−operatively.

Secondary aims:

  1. To compare the recovery of ankle function and quality of life between the two study groups from 3 months to 1 year post ankle fracture
  2. To compare complications between the two groups.
  3. To conduct a health economic analysis between the two groups as indicated

Research Design: Combined Randomised and Observational Study

  • American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire [ Time Frame: 12 months ]
    American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
  • PCS of Short Form (SF)-12v2 [ Time Frame: 12 months ]
    SF-12 version 2 Health Survey


    • Original Primary Outcome:

    • AAOS Foot and Ankle Questionnaire [ Time Frame: 12 months ]
      American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
    • SF-12v2 [ Time Frame: 12 months ]
      SF-12 version 2 Health Survey


    Current Secondary Outcome:

    • Complications [ Time Frame: 6 weeks, 3, 6 and 12 months ]
      Late surgery Infection Neurovascular complication Mortality
    • American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire [ Time Frame: 3 and 6 months ]
      American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
    • MCS of Short Form (SF)-12v2 [ Time Frame: 3, 6 and 12 months ]
      Short Form (SF)-12v2
    • PCS Short Form (SF)-12v2 [ Time Frame: 3 and 6 months ]
      Short Form (SF)-12v2


    Original Secondary Outcome: Complications [ Time Frame: 2 and 6 weeks. 3, 6, 12 months ]

    Late surgery Infection Work Status Length of inpatient stay Mortality


    Information By: The University of New South Wales

    Dates:
    Date Received: May 28, 2010
    Date Started: August 2010
    Date Completion:
    Last Updated: June 22, 2015
    Last Verified: June 2015