Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT00888550
Status:
COMPLETED
Last Update Posted:
2010-09-29
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2009-04-23', 'studyFirstSubmitQcDate': '2009-04-24', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences across time and between groups for pain and range of motion', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Tibia Fracture']}, 'descriptionModule': {'briefSummary': "Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.\n\nThe purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail\n\nExclusion Criteria:\n\n* Pregnant Women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT00888550', 'briefTitle': 'Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures', 'orgStudyIdInfo': {'id': 'DHMC07-0216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Splinting', 'interventionNames': ['Procedure: Post-Op Splinting']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. No Splinting', 'interventionNames': ['Procedure: No Splinting']}], 'interventions': [{'name': 'Post-Op Splinting', 'type': 'PROCEDURE', 'description': 'Splint will applied post-operatively and will remain on for two weeks', 'armGroupLabels': ['1. Splinting']}, {'name': 'No Splinting', 'type': 'PROCEDURE', 'description': 'Patient will be discharged post-operatively without a splint on their lower leg.', 'armGroupLabels': ['2. No Splinting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Steven Morgan, MD', 'oldOrganization': 'Denver Health Medical Center'}}}}