Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Ankle Fractures Clinical Trial

— CROSSBAT  

Official title:

Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134094
• Other study ID #: CROSSBAT
• 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

• Ankle Fractures
• Fractures, Bone

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