Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01493167
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2011-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on Wood-plastic Composite for Circumferential Casting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nina.c.lindfors@hus.fi', 'phone': '358 9 4711', 'title': 'Dr Nina Linfors', 'organization': 'Helsinki University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1-6 weeks (whole treatment period)', 'description': 'All Adverse Events were monitored/collected, but none observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Limb Casting/Splinting', 'description': 'Patient age 0-90 years. Patient treatment requires extremity immobilization\n\nlimb casting/splinting: ankle and arm cast', 'otherNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficient Casting With Woodcast Circular System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Limb Casting/Splinting', 'description': 'Patient age 0-90 years. Patient treatment requires extremity immobilization\n\nlimb casting/splinting: ankle and arm cast'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 - 6 weeks', 'description': 'Efficient casting conduc ted with Novel Woodcast material', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Limb Casting/Splinting', 'description': 'Patient age 0-90 years. Patient treatment requires extremity immobilization\n\nlimb casting/splinting: ankle and arm cast'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Woodcast Circular System Casts', 'description': 'Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2011-12-13', 'resultsFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-26', 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficient Casting With Woodcast Circular System', 'timeFrame': '1 - 6 weeks', 'description': 'Efficient casting conduc ted with Novel Woodcast material'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cast', 'splint', 'circumferential casting', 'casting techniques', 'fracture in extremity'], 'conditions': ['Bone Fracture', 'Radius Fracture', 'Ankle Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.', 'detailedDescription': 'An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient treatment involves circular casting;\n* age 0-90 years;\n* mother tongue finnish or swedish\n\nExclusion Criteria:\n\n* open fracture;\n* other fractures or a previous fracture;\n* a previous or simultaneous tendon-, nerve-, or vascular injury to the extremity yo be treated;\n* a multiple injured extremity;\n* decreased co-operation of the patient;\n* malignancy;\n* an illness affecting the general health.'}, 'identificationModule': {'nctId': 'NCT01493167', 'acronym': 'WOODCAST', 'briefTitle': 'Study on Wood-plastic Composite for Circumferential Casting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Onbone Oy'}, 'officialTitle': 'Study on Circumferential Casting Techniques With WOODCAST', 'orgStudyIdInfo': {'id': '37/13/03/02/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'limb casting/splinting', 'description': 'Patient age 0-90 years. Patient treatment requires extremity immobilization', 'interventionNames': ['Other: limb casting/splinting']}], 'interventions': [{'name': 'limb casting/splinting', 'type': 'OTHER', 'description': 'ankle and arm cast', 'armGroupLabels': ['limb casting/splinting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Nina C Lindfors, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onbone Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}