Combined Randomised and Observational Study of Type B Ankle Fracture Treatment (CROSSBAT)

This study is currently recruiting participants.
Verified January 2012 by The University of New South Wales
Sponsor:
Collaborators:
Whitlam Orthopaedic Research Centre
CROSSBAT Investigators
Information provided by (Responsible Party):
Rajat Mittal, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01134094
First received: May 28, 2010
Last updated: January 24, 2012
Last verified: January 2012

May 28, 2010
January 24, 2012
August 2010
December 2013   (final data collection date for primary outcome measure)
  • American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
  • Short Form (SF)-12v2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SF-12 version 2 Health Survey
  • AAOS Foot and Ankle Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
  • SF-12v2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SF-12 version 2 Health Survey
Complete list of historical versions of study NCT01134094 on ClinicalTrials.gov Archive Site
  • Complications [ Time Frame: 2 and 6 weeks. 3, 6, 12 months, 2 and 3 years ] [ Designated as safety issue: No ]
    Late surgery Infection Neurovascular complication Mortality
  • American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire [ Time Frame: 3 and 6 months, 2 and 3 years ] [ Designated as safety issue: No ]
    American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
  • Short Form (SF)-12v2 [ Time Frame: 3 and 6 months and 2 and 3 years ] [ Designated as safety issue: No ]
    Short Form (SF)-12v2
Complications [ Time Frame: 2 and 6 weeks. 3, 6, 12 months ] [ Designated as safety issue: No ]
Late surgery Infection Work Status Length of inpatient stay Mortality
Not Provided
Not Provided
 
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

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.

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 these injuries are unlikely to cause post−traumatic arthritis. Furthermore, 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 without 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 3 years post ankle fracture
  2. To compare complications between the two groups.
  3. To conduct a health economic analysis between the two groups.

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 receive a specially formatted Patient Diary to 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ankle Fractures
  • Procedure: Open reduction internal fixation of the ankle
    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.
  • Procedure: Non Operative
    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.
  • Active Comparator: Non-Operative
    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.
    Intervention: Procedure: Non Operative
  • Active Comparator: Operative
    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.
    Intervention: Procedure: Open reduction internal fixation of the ankle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2016
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture
  • Patients aged between 18 and 65 inclusive.
  • Mobilising unaided/independently pre-injury
  • Willingness to be followed up for 12 months

Exclusion Criteria:

  • Medically unfit for general anaesthesia/surgery
  • Talar shift - Medial clear space 2mm or more than the superior clear space on anterior-posterior (AP) view of the ankle.
  • Dislocation on presentation
  • Other fractures/dislocations
  • Open injury
  • Skeletally immature patients
  • Previous trauma or surgery to the affected ankle
  • Inability to consent
  • Pregnancy
  • Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation
  • Non-English speaking
Both
18 Years to 65 Years
No
Contact: Rajat Mittal, MBBS +61 2 8738 3947 rajatmittal.syd@gmail.com
Australia
 
NCT01134094
CROSSBAT
Yes
Rajat Mittal, The University of New South Wales
The University of New South Wales
  • Whitlam Orthopaedic Research Centre
  • CROSSBAT Investigators
Principal Investigator: Ian Harris, MBBS, PhD, FRACS University of New South Wales, Whitlam Orthopaedic Research Centre
Principal Investigator: Rajat Mittal, Bsc (Med) MBBS University of New South Wales, Whitlam Orthopaedic Research Centre
The University of New South Wales
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP