Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT01134094
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2010-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2010-05-28', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire', 'timeFrame': '12 months', 'description': 'American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire'}, {'measure': 'PCS of Short Form (SF)-12v2', 'timeFrame': '12 months', 'description': 'SF-12 version 2 Health Survey'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'Late surgery Infection Neurovascular complication Mortality'}, {'measure': 'American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire', 'timeFrame': '3 and 6 months', 'description': 'American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire'}, {'measure': 'MCS of Short Form (SF)-12v2', 'timeFrame': '3, 6 and 12 months', 'description': 'Short Form (SF)-12v2'}, {'measure': 'PCS Short Form (SF)-12v2', 'timeFrame': '3 and 6 months', 'description': 'Short Form (SF)-12v2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Undisplaced', 'Ankle Fracture', 'Weber B'], 'conditions': ['Ankle Fractures']}, 'referencesModule': {'references': [{'pmid': '28348185', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Background:\n\nAnkle 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.\n\nThe 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.\n\nThe 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.\n\nAim:\n\nPrimary 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.\n\nSecondary aims:\n\n1. 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\n2. To compare complications between the two groups.\n3. To conduct a health economic analysis between the two groups as indicated\n\nResearch Design: Combined Randomised and Observational Study\n\nMethods:\n\nRecruitment:\n\nAll 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\n\nWritten, informed consent will be obtained.\n\nEligible 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.\n\nTypical demographic, anthropometric and surgical details (where appropriate) will be recorded for contextual reference.\n\nSurgical intervention:\n\nThe 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.\n\nNon-Operative management:\n\nPatients 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.\n\nOther 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.\n\nOutcomes will be collected and results will be reported in peer-reviewed journals after appropriate statistical analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture\n* Patients aged between 18 and 65 inclusive.\n* No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle.\n* Closed injury\n* No concurrent fractures/dislocations\n* Mobilising unaided/independently pre-injury\n* Willingness to be followed up for 12 months\n* Able to provide informed written consent\n\nExclusion Criteria:\n\n* Medically fit for general anaesthesia/surgery\n* Dislocation on presentation\n* Skeletally immature patients\n* Previous trauma or surgery to the affected ankle\n* Pregnancy\n* Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT01134094', 'acronym': 'CROSSBAT', 'briefTitle': 'Combined Randomised and Observational Study of Type B Ankle Fracture Treatment', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'Combined Randomised and Observational Study of Type B Ankle Fracture Treatment', 'orgStudyIdInfo': {'id': 'CROSSBAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Operative', 'description': '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.', 'interventionNames': ['Procedure: Non Operative']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Operative', 'description': '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.', 'interventionNames': ['Procedure: Open reduction internal fixation of the ankle']}], 'interventions': [{'name': 'Open reduction internal fixation of the ankle', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Operative']}, {'name': 'Non Operative', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Non-Operative']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'city': 'Brisbane', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital"}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Campbelltown Hospital', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2229', 'city': 'Caringbah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sutherland Hospital', 'geoPoint': {'lat': -34.03534, 'lon': 151.12468}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St. George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Alfred Hospital'}, {'zip': '2305', 'city': 'New Lambton', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92838, 'lon': 151.7085}}, {'zip': '3050', 'city': 'Parkville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -31.9809, 'lon': 150.86276}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Cairns', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Cairns Base Hospital', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'city': 'Mackay', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mackay Base Hospital', 'geoPoint': {'lat': -21.15345, 'lon': 149.16554}}, {'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nambour Hospital', 'geoPoint': {'lat': -26.62613, 'lon': 152.95941}}, {'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Elizabeth Vale', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Lyell McEwin Hospital', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Ian Harris, MBBS, PhD, FRACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales, Whitlam Orthopaedic Research Centre'}, {'name': 'Rajat Mittal, Bsc (Med) MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales, Whitlam Orthopaedic Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'collaborators': [{'name': 'CROSSBAT Investigators', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rajat Mittal', 'investigatorAffiliation': 'The University of New South Wales'}}}}