Ankle FracturesCROSSBATNCT01134094
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
A study testing Open reduction internal fixation of the ankle and Non Operative in people with Ankle Fractures, run by The University of New South Wales at 21 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Open reduction internal fixation of the ankle and Non Operative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 21 sitesAustralia
- Study dates
- Aug 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Australia21 sites
Royal Adelaide Hospital
Adelaide, South Australia
Flinders Medical Centre
Bedford Park, South Australia
Royal Brisbane and Women's Hospital
Brisbane, New South Wales
Cairns Base Hospital
Cairns, Queensland
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Royal Prince Alfred
Camperdown, New South Wales
Sutherland Hospital
Caringbah, New South Wales, 2229
Lyell McEwin Hospital
Elizabeth Vale, South Australia
Canberra Hospital
Garran, Australian Capital Territory
St. George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
Mackay Base Hospital
Mackay, Queensland
The Alfred Hospital
Melbourne, New South Wales, 3004
Nambour Hospital
Nambour, Queensland
John Hunter Hospital
New Lambton, New South Wales, 2305
The Royal Melbourne Hospital
Parkville, New South Wales, 3050
Sir Charles Gairdner Hospital
Perth, Western Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031
Westmead Hospital
Westmead, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales
Princess Alexandra Hospital
Woolloongabba, Queensland
About this study
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.
Read the detailed 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:
- 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
- To compare complications between the two groups.
- 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.
- Conditions
- Ankle Fractures
- Being tested
- Open reduction internal fixation of the ankle, Non Operative
- Keywords
- Undisplaced, Ankle Fracture, Weber B
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction internal fixation of the ankleProcedure or surgery
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 OperativeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Operative | Active comparator | 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. Receives: Procedure: Non Operative |
| Operative | Active comparator | 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. Receives: Procedure: Open reduction internal fixation of the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
Measured: 12 months
PCS of Short Form (SF)-12v2
SF-12 version 2 Health Survey
Measured: 12 months
Secondary outcomes (4)
Complications
Late surgery Infection Neurovascular complication Mortality
Measured: 6 weeks, 3, 6 and 12 months
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
Measured: 3 and 6 months
MCS of Short Form (SF)-12v2
Short Form (SF)-12v2
Measured: 3, 6 and 12 months
PCS Short Form (SF)-12v2
Short Form (SF)-12v2
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- CROSSBAT Investigators
- Responsible party
- Principal investigator, Rajat Mittal, The University of New South Wales
- Investigators
- Ian Harris, MBBS, PhD, FRACS, Principal investigator, University of New South Wales, Whitlam Orthopaedic Research CentreRajat Mittal, Bsc (Med) MBBS, Principal investigator, University of New South Wales, Whitlam Orthopaedic Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134094
- Sponsor's protocol ID
- CROSSBAT
- Acronym
- CROSSBAT
- Status last verified
- Jun 2015
- First submitted
- 28 May 2010
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28348185
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
- ClinicalTrials.gov ID
- NCT01134094
- Acronym / sponsor ID
- CROSSBAT / CROSSBAT
- Conditions
- Ankle Fractures
- Keywords
- Undisplaced, Ankle Fracture, Weber B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- CROSSBAT Investigators
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- To compare complications between the two groups.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Operative | Active comparator | Procedure: Non OperativePatients 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 comparator | Procedure: Open reduction internal fixation of the ankleThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Medically fit for general anaesthesia/surgery
- Dislocation on presentation
- Skeletally immature patients
- Previous trauma or surgery to the affected ankle
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction internal fixation of the ankleThe 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 or surgery | Operative |
| Non OperativePatients 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 or surgery | Non-Operative |
Primary outcome
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
Time frame: 12 months
American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
PCS of Short Form (SF)-12v2
Time frame: 12 months
SF-12 version 2 Health Survey
4 secondary outcomes
Complications
Time frame: 6 weeks, 3, 6 and 12 months
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
Time frame: 3 and 6 months
MCS of Short Form (SF)-12v2
Time frame: 3, 6 and 12 months
PCS Short Form (SF)-12v2
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 28348185Mittal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Harris, MBBS, PhD, FRACS principal investigator
University of New South Wales, Whitlam Orthopaedic Research Centre
Rajat Mittal, Bsc (Med) MBBS principal investigator
University of New South Wales, Whitlam Orthopaedic Research Centre
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction internal fixation of the ankle and Non Operative in people with Ankle Fractures, run by The University of New South Wales at 21 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.