Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
Condition: Ankle Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

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 description: 
      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

      Methods:

      Recruitment:

      All consecutive patients who present to a recruiting hospital with a distal fibular fracture
      during the study period will be screened for eligibility. In most hospitals, all surgeons on
      the on-call roster will participate in the study. Consenting patients of the surgeons who
      have agreed to participate in the randomised arm of the trial will be invited to have their
      treatment randomised. Patients of surgeons involved in the observational component of the
      study will be invited to be included in the observational arm together with the patients who
      decline to be randomised, but consent to follow-up

      Written, informed consent will be obtained.

      Eligible patients of surgeons participating in the randomised arm will have the option of
      having their treatment randomised. If consent is given, the surgeon will call a central
      number for patient allocation that is available 24 hours per day, 7 days per week. The
      randomisation schedule will be prepared and administered by an external party not otherwise
      involved in the study. If the patient declines randomisation, treatment will be determined
      after surgeon-patient discussion. Eligible patients of surgeons involved in the observational
      arm will also have their treatment provided (operative or non-operative) as per usual surgeon
      practice.

      Typical demographic, anthropometric and surgical details (where appropriate) will be recorded
      for contextual reference.

      Surgical intervention:

      The surgical technique for each patient managed operatively, in both the observational and
      randomised arms of the study, will include fixation using a plate and screws. Any adverse
      intra-operative or post-operative event will be recorded. This includes but is not limited to
      death, infection, VTE and neurovascular injury. Post-operatively, all patients will be non
      weight bearing and placed in a below-knee plaster cast or walking boot. Discharge from
      hospital will be determined by the patient's ability to walk 25 m unaided by standby
      assistance as determined by a physiotherapist. The treating surgeon will review the patient
      after 10-14 days for assessment of the wound, removal of sutures and change of cast to a
      fibreglass cast or walking boot (cam walker). The patient will then be allowed to WBAT
      (weight bearing as tolerated) for a further 4 weeks. This protocol represents usual
      post-operative practice for this injury, as determined through meetings with the Australian
      Orthopaedic Trauma Society.

      Non-Operative management:

      Patients who are treated non-operatively will be treated with a walking boot and allowed
      WBAT. Discharge from hospital will be determined as for the surgical arm. All patients will
      be reviewed between 7 and 14 days post injury with repeat radiographs by the treating
      surgeon. This represents usual non-operative treatment for this injury.

      Other management decisions such as need for antibiotics, VTE prophylaxis or anaesthetic type
      will be as per usual care for that institution and recorded by the research team. Referral
      for further physiotherapy post removal of cast or boot (either study arm) will be based on
      the presence of overt ankle stiffness affecting gait. The use of physiotherapy (type and
      duration) will be noted. Specific prescription of the type of physiotherapy is not possible
      as patients will be free to access public and private services. Study participants will
      record all hospitalisations and visits to any health professional. They will be required to
      report the main reason for such health service occasions during the first year of follow-up
      period.

      Outcomes will be collected and results will be reported in peer-reviewed journals after
      appropriate statistical analysis.
    

Intervention name(s): Open reduction internal fixation of the ankle; Non Operative
Intervention type(s): Procedure; Procedure
Intervention description(s): The specific procedure for each patient managed operatively, both in the observational study and the RCT, will be determined by the operating surgeon. Any adverse intra-operative or post-operative event will be recorded. This includes but is not limited to death, infection and neurovascular injury. Post operatively, all patients will be NWB (non weight bearing) and placed in a POP (plaster of paris) below knee cast or walking boot. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. The treating surgeon will review the patients after 10-14 days for a wound review, removal of sutures and change of cast to a fibreglass cast or walking boot (cam walker). The patient will be WBAT (weight bearing as tolerated) for a further 4 weeks.; Patients who are treated non-operatively will be treated with a walking boot and allowed WBAT. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. All patients will be reviewed between 7 and 14 days post injury with repeat x-rays by the treating surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Undisplaced; Ankle Fracture; Weber B