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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01134094
Other study ID # CROSSBAT
Secondary ID
Status Completed
Phase N/A
First received May 28, 2010
Last updated June 22, 2015
Start date August 2010
Est. completion date September 2014

Study information

Verified date June 2015
Source The University of New South Wales
Contact n/a
Is FDA regulated No
Health authority Australia: New South Wales Health
Study type Interventional

Clinical Trial 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.


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 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 minimal 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 1 year post ankle fracture

2. To compare complications between the two groups.

3. To conduct a health economic analysis between the two groups as indicated

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 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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Flinders Medical Centre Bedford Park South Australia
Australia Royal Brisbane and Women's Hospital Brisbane New South Wales
Australia Cairns Base Hospital Cairns Queensland
Australia Campbelltown Hospital Campbelltown New South Wales
Australia Royal Prince Alfred Camperdown New South Wales
Australia Sutherland Hospital Caringbah New South Wales
Australia Lyell McEwin Hospital Elizabeth Vale South Australia
Australia Canberra Hospital Garran Australian Capital Territory
Australia St. George Hospital Kogarah New South Wales
Australia Liverpool Hospital Liverpool New South Wales
Australia Mackay Base Hospital Mackay Queensland
Australia The Alfred Hospital Melbourne New South Wales
Australia Nambour Hospital Nambour Queensland
Australia John Hunter Hospital New Lambton New South Wales
Australia The Royal Melbourne Hospital Parkville New South Wales
Australia Sir Charles Gairdner Hospital Perth Western Australia
Australia Prince of Wales Hospital Randwick New South Wales
Australia Westmead Hospital Westmead New South Wales
Australia Wollongong Hospital Wollongong New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland

Sponsors (2)

Lead Sponsor Collaborator
The University of New South Wales CROSSBAT Investigators

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire 12 months No
Primary PCS of Short Form (SF)-12v2 SF-12 version 2 Health Survey 12 months No
Secondary Complications Late surgery Infection Neurovascular complication Mortality 6 weeks, 3, 6 and 12 months No
Secondary American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire 3 and 6 months No
Secondary MCS of Short Form (SF)-12v2 Short Form (SF)-12v2 3, 6 and 12 months No
Secondary PCS Short Form (SF)-12v2 Short Form (SF)-12v2 3 and 6 months No
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