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
  Purpose

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.


Condition Intervention
Ankle Fractures
Procedure: Open reduction internal fixation of the ankle
Procedure: Non Operative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
Study Start Date: August 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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.

  Hide Detailed Description

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134094

Contacts
Contact: Rajat Mittal, MBBS +61 2 8738 3947 rajatmittal.syd@gmail.com

Locations
Australia, Australian Capital Territory
Canberra Hospital Recruiting
Garran, Australian Capital Territory, Australia
Contact: Paul Smith, MBBS, FAOrthA, FRACS    62443701      
Principal Investigator: Paul Smith, MBBS, FAOrthA, FRACS         
Australia, New South Wales
Royal Brisbane and Women's Hospital Recruiting
Brisbane, New South Wales, Australia
Contact: Kevin Tetsworth, MBBS, FAOrthA, FRACS    36368129      
Principal Investigator: Kevin Tetsworth, MBBS, FAOrthA, FRACS         
Campbelltown Hospital Recruiting
Campbelltown, New South Wales, Australia, 2560
Principal Investigator: Tim O'Carrigan, MBBS, FRACS (Ortho).         
Royal Prince Alfred Recruiting
Camperdown, New South Wales, Australia
Contact: Jeff Petchell, MBBS, FAOrthA, FRACS    95172630      
Principal Investigator: Jeff Petchell, MBBS, FAOrthA, FRACS         
Sutherland Hospital Recruiting
Caringbah, New South Wales, Australia, 2229
Principal Investigator: Ian Harris, MBBS, PhD, FRACS         
St. George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Principal Investigator: Ian Harris, MBBS, PhD, FRACS         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Ian Harris, MBBS, PhD, FRACS    +61 2 8738 3898    ian.harris@sswahs.nsw.gov.au   
Principal Investigator: Ian Harris, MBBS, PhD, FRACS         
Sub-Investigator: Sam Adie, MBBS, MMed(Clin Epi)         
Sub-Investigator: Justine Naylor, PhD, B AppSc (Physio)         
Principal Investigator: Rajat Mittal, MBBS         
The Alfred Hospital Not yet recruiting
Melbourne, New South Wales, Australia, 3004
Principal Investigator: Susan Liew, BSc MBBS MSc MRSC FRCS FRACS.         
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia, 2305
Principal Investigator: Zsolt Balogh, MD, PhD, FRACS(ortho)         
The Royal Melbourne Hospital Recruiting
Parkville, New South Wales, Australia, 3050
Principal Investigator: Andrew Bucknill, BSc MBBS MSc MRSC FRCS FRACS.         
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Principal Investigator: Jonathan Mulford, BSc, MBBS, FRACS (Ortho)         
Westmead Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Robert Molnar, MBBS, FRACS (Ortho).         
Wollongong Hospital Recruiting
Wollongong, New South Wales, Australia
Contact: Aziz Bhimani, MBBS, FAOrthA, FRACS    42299116      
Principal Investigator: Aziz Bhimani, MBBS, FAOrthA, FRACS         
Australia, Queensland
Cairns Base Hospital Recruiting
Cairns, Queensland, Australia
Contact: Chris Morrey, MBBS, FAOrthA, FRACS    40520929      
Principal Investigator: Chris Morrey, MBBS, FRACS, FAOrthA         
Mackay Base Hospital Recruiting
Mackay, Queensland, Australia
Contact: Herwig Drobetz, MBBS, FAOrthA, FRACS    49686309      
Principal Investigator: Herwig Drobetz, MBBS, FRACS, FAOrthA         
Nambour Hospital Recruiting
Nambour, Queensland, Australia
Contact: Russell Bourne, MBBS, FAOrthA, FRACS    54440355      
Principal Investigator: Russell Bourne, MBBS, FAOrthA, FRACS         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia
Contact: Lawrie Malisano, MBBS, FAOrthA, FRACS    38346680      
Principal Investigator: Lawrie Malisano, MBBS, FAOrthA, RACS         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Mellcik Chehade, MBBS, FAOrthA, FRACS    82225661      
Principal Investigator: Mellick Chehade, MBBS, FAOrthA, FRACS         
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia
Contact: Peter Tamblyn, MBBS, FAOrthA, FRACS    8204 4673      
Principal Investigator: Peter Tamblyn, MBBS, FAOrthA, FRACS         
Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia
Contact: Paul Allcock, MBBS, FAOrthA, FRACS    8182 9835      
Principal Investigator: Paul Allcock, MBBS, FAOrthA, FRACS         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia
Contact: Jonathan Spencer, MBBS, FAOrthA, FRACS    08 9346 1499      
Principal Investigator: Jonathan Spencer, MBBS, FAOrthA, FRACS         
Sponsors and Collaborators
The University of New South Wales
Whitlam Orthopaedic Research Centre
CROSSBAT Investigators
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
  More Information

No publications provided

Responsible Party: Rajat Mittal, Principal Investigator, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01134094     History of Changes
Other Study ID Numbers: CROSSBAT
Study First Received: May 28, 2010
Last Updated: January 24, 2012
Health Authority: Australia: New South Wales Health

Keywords provided by The University of New South Wales:
Undisplaced
Ankle Fracture
Weber B

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014