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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01134094




Registration number
NCT01134094
Ethics application status
Date submitted
28/05/2010
Date registered
31/05/2010
Date last updated
24/06/2015

Titles & IDs
Public title
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
Scientific title
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
Secondary ID [1] 0 0
CROSSBAT
Universal Trial Number (UTN)
Trial acronym
CROSSBAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Open reduction internal fixation of the ankle
Treatment: Surgery - Non Operative

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.

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.


Treatment: Surgery: 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.

Treatment: Surgery: 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 code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
PCS of Short Form (SF)-12v2
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Complications
Timepoint [1] 0 0
6 weeks, 3, 6 and 12 months
Secondary outcome [2] 0 0
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
Timepoint [2] 0 0
3 and 6 months
Secondary outcome [3] 0 0
MCS of Short Form (SF)-12v2
Timepoint [3] 0 0
3, 6 and 12 months
Secondary outcome [4] 0 0
PCS Short Form (SF)-12v2
Timepoint [4] 0 0
3 and 6 months

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 0 0
Royal Prince Alfred - Camperdown
Recruitment hospital [5] 0 0
Sutherland Hospital - Caringbah
Recruitment hospital [6] 0 0
St. George Hospital - Kogarah
Recruitment hospital [7] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [12] 0 0
Westmead Hospital - Westmead
Recruitment hospital [13] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [14] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [15] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [16] 0 0
Nambour Hospital - Nambour
Recruitment hospital [17] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [18] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [19] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [20] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [21] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
- Camperdown
Recruitment postcode(s) [5] 0 0
2229 - Caringbah
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
2170 - Liverpool
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
2305 - New Lambton
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
2031 - Randwick
Recruitment postcode(s) [12] 0 0
2145 - Westmead
Recruitment postcode(s) [13] 0 0
- Wollongong
Recruitment postcode(s) [14] 0 0
- Cairns
Recruitment postcode(s) [15] 0 0
- Mackay
Recruitment postcode(s) [16] 0 0
- Nambour
Recruitment postcode(s) [17] 0 0
- Woolloongabba
Recruitment postcode(s) [18] 0 0
- Adelaide
Recruitment postcode(s) [19] 0 0
- Bedford Park
Recruitment postcode(s) [20] 0 0
- Elizabeth Vale
Recruitment postcode(s) [21] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CROSSBAT Investigators
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01134094
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Harris, MBBS, PhD, FRACS
Address 0 0
University of New South Wales, Whitlam Orthopaedic Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01134094