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

This study has been completed.
Sponsor:
Collaborator:
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: March 4, 2015
Last verified: March 2015
  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 and 12 months ] [ Designated as safety issue: No ]
    Late surgery Infection Neurovascular complication Mortality

  • American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire

  • Short Form (SF)-12v2 [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Short Form (SF)-12v2


Enrollment: 160
Study Start Date: August 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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.

  Show Detailed Description

  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
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: NCT01134094

Locations
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia
Australia, New South Wales
Royal Brisbane and Women's Hospital
Brisbane, New South Wales, Australia
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Royal Prince Alfred
Camperdown, New South Wales, Australia
Sutherland Hospital
Caringbah, New South Wales, Australia, 2229
St. George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
The Alfred Hospital
Melbourne, New South Wales, Australia, 3004
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
The Royal Melbourne Hospital
Parkville, New South Wales, Australia, 3050
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
Cairns Base Hospital
Cairns, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Nambour Hospital
Nambour, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Sponsors and Collaborators
The University of New South Wales
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: March 4, 2015
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:
Ankle Fractures
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2015