Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-06 @ 12:35 AM
Study NCT ID:
NCT03107767
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A prospective cohort, following the introduction of an evidence based algorithm, will be compared to a matched historical cohort from the previous years.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in re-operation rate', 'timeFrame': 'one year', 'description': 'Change in re-operation rate following introduction of PRO malleol algorithm'}, {'measure': 'Rate of surgery for isolated lateral ankle fractures', 'timeFrame': 'one year', 'description': 'Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm'}], 'secondaryOutcomes': [{'measure': 'SF 36', 'timeFrame': 'day 0 and 12 months', 'description': 'SF 36 before fracture and at 12 months'}, {'measure': 'Ollerud Molander Ankle Score', 'timeFrame': 'Before fracture, 6 weeks, 12 weeks and 1 year'}, {'measure': 'Forgotten Joint Score', 'timeFrame': 'Before fracture, 6 weeks, 12 weeks and 1 year', 'description': 'Before fracture, 6 weeks, 12 weeks and 1 year'}, {'measure': 'Rate of complications not requiring surgery', 'timeFrame': 'One year', 'description': 'DVT, Nerve damage,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Fractures', 'Surgery', 'Syndesmotic Injuries', 'Posterior Malleolus Fractures']}, 'descriptionModule': {'briefSummary': 'There is a high incidence of re-operations after surgery for ankle fractures. According to the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is almost 10%.\n\nWe are conducting a study on the efficacy of an evidence based algorithm for the treatment of ankle fractures.', 'detailedDescription': 'Treatment of ankle fractures is complex and includes assessment of fracture pattern, severity of soft-tissue involvement and general health- and functional status of the patients. Historically most fractures, undisplaced as well as displaced, were treated non-operatively with acceptable results but in recent years there is an increasing trend towards operative management of unstable fractures. Techniques for operative management of ankle fractures are varied and assessment of instability is mainly based on classic x-ray classification systems such as Lauge-Hansen or the AO that are difficult to reproduce\\[6\\].\n\nWe hypothesize that a standardized and evidence based approach to ankle fracture management will lead to a decrease in re-operation rate.\n\nThe aim of this study is to standardize the management of ankle fractures in our department, by introducing an algorithm based on best evidence present. We want to investigate:\n\n1. The effect of this algorithm on the re-operation rate of surgically treated ankle fractures in a two-year prospective observational setup with a minimum of one-year of follow-up.\n2. The need for surgery and functional outcome of patients with isolated lateral malleolus fractures in which the treatment is dictated by ankle stability assessed on weight bearing radiographs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.\n\nExclusion Criteria:\n\n* Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire'}, 'identificationModule': {'nctId': 'NCT03107767', 'acronym': 'PRO-Malleol', 'briefTitle': 'Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'The PRO-malleol Study', 'orgStudyIdInfo': {'id': 'PRO-Malleol study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prospective Cohort', 'description': 'The prospective cohort following introduction of the evidence based algorithm for ankle fractures.', 'interventionNames': ['Procedure: PRO-malleol algorithm']}, {'type': 'NO_INTERVENTION', 'label': 'Historical Cohort', 'description': 'Patients treated before introduction of algorithm. Matched to prospective cohort for comparison'}], 'interventions': [{'name': 'PRO-malleol algorithm', 'type': 'PROCEDURE', 'description': 'An evidence based algorithm for ankle fractures', 'armGroupLabels': ['Prospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter T Tengberg, MD', 'role': 'CONTACT', 'email': 'ptofttengberg@gmail.com', 'phone': '+4561663676'}, {'name': 'Peter T Tengberg, MD', 'role': 'CONTACT', 'email': 'peter.toft.tengberg@regionh.dk', 'phone': '+4522971007'}, {'name': 'Peter T Tengberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be anonymized and openly shared with any who requests it, after study publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, PhD', 'investigatorFullName': 'Peter Toft Tengberg', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}