Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-23 @ 12:50 PM
Study NCT ID:
NCT01758835
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013165', 'term': 'Splints'}, {'id': 'C119975', 'term': 'POLR1G protein, human'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olerud-Molander score', 'timeFrame': '1 year', 'description': 'Ankle functional outcome measure'}], 'secondaryOutcomes': [{'measure': 'FAOS', 'timeFrame': '1 year', 'description': 'Foot and Ankle Outcome Score'}, {'measure': 'VAS', 'timeFrame': '1 year', 'description': 'Visual Analogue Scale pain and function'}, {'measure': 'RAND 36 Health item survey', 'timeFrame': '1 year', 'description': 'Quality of life measurement'}, {'measure': 'Fracture healing', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ER-stress-test negative', 'unimalleolar', 'fibula', 'Weber-B fractures'], 'conditions': ['Lateral Malleolus Fractures']}, 'referencesModule': {'references': [{'pmid': '30674451', 'type': 'DERIVED', 'citation': 'Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.'}]}, 'descriptionModule': {'briefSummary': 'PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.', 'detailedDescription': 'Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stable Weber-B type fibula fracture\n* ER-stress negative\n* 16 or over years old\n* Willingness to participate on study proved by a signature and date\n* Walking without aid before accident\n* Treatment started within 7 days from injury\n\nExclusion Criteria:\n\n* Prior ankle fracture or significant fracture in the area of ankle or leg\n* Bilateral ankle fracture\n* Pathological fracture\n* Diabetes mellitus or an other significant periferial neuropathy\n* municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital\n* Patient's understanding or co-operation inadequate"}, 'identificationModule': {'nctId': 'NCT01758835', 'briefTitle': 'PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.', 'orgStudyIdInfo': {'id': 'OYSrctAnkle5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Splint 3 weeks', 'description': 'Removable ankle brace/splint', 'interventionNames': ['Other: Splint 3 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cast 3 weeks', 'description': 'Below-the-knee cast (glass fiber)', 'interventionNames': ['Other: Cast 3 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cast 6 weeks', 'description': 'Below-the-knee cast (glass fiber)', 'interventionNames': ['Other: Cast 6 weeks']}], 'interventions': [{'name': 'Splint 3 weeks', 'type': 'OTHER', 'description': 'A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.', 'armGroupLabels': ['Splint 3 weeks']}, {'name': 'Cast 3 weeks', 'type': 'OTHER', 'description': 'A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.', 'armGroupLabels': ['Cast 3 weeks']}, {'name': 'Cast 6 weeks', 'type': 'OTHER', 'description': 'standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.', 'armGroupLabels': ['Cast 6 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'OYS, kirurgian klinkka, Oulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Harri J Pakarinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oulu University Hospital'}, {'name': 'Tero HJ Kortekangas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgeon, MD, PhD', 'investigatorFullName': 'Harri Pakarinen', 'investigatorAffiliation': 'University of Oulu'}}}}