Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
CROSSBAT
1 other identifier
interventional
160
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJune 24, 2015
June 1, 2015
4.1 years
May 28, 2010
June 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
12 months
PCS of Short Form (SF)-12v2
SF-12 version 2 Health Survey
12 months
Secondary Outcomes (4)
Complications
6 weeks, 3, 6 and 12 months
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
3 and 6 months
MCS of Short Form (SF)-12v2
3, 6 and 12 months
PCS Short Form (SF)-12v2
3 and 6 months
Study Arms (2)
Non-Operative
ACTIVE COMPARATORPatients 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.
Operative
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture
- Patients aged between 18 and 65 inclusive.
- No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle.
- Closed injury
- No concurrent fractures/dislocations
- Mobilising unaided/independently pre-injury
- Willingness to be followed up for 12 months
- Able to provide informed written consent
You may not qualify if:
- Medically fit for general anaesthesia/surgery
- Dislocation on presentation
- Skeletally immature patients
- Previous trauma or surgery to the affected ankle
- Pregnancy
- Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of New South Waleslead
- CROSSBAT Investigatorscollaborator
Study Sites (21)
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Brisbane and Women's Hospital
Brisbane, New South Wales, Australia
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Royal Prince Alfred
Camperdown, New South Wales, Australia
Sutherland Hospital
Caringbah, New South Wales, 2229, Australia
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
The Alfred Hospital
Melbourne, New South Wales, 3004, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
The Royal Melbourne Hospital
Parkville, New South Wales, 3050, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Cairns Base Hospital
Cairns, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Nambour Hospital
Nambour, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Related Publications (1)
Mittal R, Harris IA, Adie S, Naylor JM; CROSSBAT Study Group. Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT). BMJ Open. 2017 Mar 27;7(3):e013298. doi: 10.1136/bmjopen-2016-013298.
PMID: 28348185DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2010
First Posted
May 31, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
June 24, 2015
Record last verified: 2015-06