Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-05 @ 3:38 PM
Study NCT ID:
NCT00580866
Status:
TERMINATED
Last Update Posted:
2016-09-07
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Progressive Splinting Status Post Elbow Fractures and Dislocations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018460', 'term': 'Fractures, Comminuted'}, {'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.obremskey@Vanderbilt.Edu', 'phone': '6159363630', 'title': 'William Obremskey', 'organization': 'Vanderbilt'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Brace Group', 'description': 'JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PT Only Group', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Elbow ROM at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brace Group', 'description': 'JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.'}, {'id': 'OG001', 'title': 'PT Only Group'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '130'}, {'value': '123', 'groupId': 'OG001', 'lowerLimit': '119', 'upperLimit': '129'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively', 'description': "The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.", 'unitOfMeasure': 'degrees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.'}, {'type': 'SECONDARY', 'title': 'Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brace Group', 'description': 'JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.'}, {'id': 'OG001', 'title': 'PT Only Group'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '29'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '27'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post-operatively', 'description': "Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brace Group', 'description': 'JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.'}, {'id': 'FG001', 'title': 'PT Only Group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brace Group', 'description': 'JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.'}, {'id': 'BG001', 'title': 'PT Only Group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-22', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-22', 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elbow ROM at 12 Months', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively', 'description': "The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion."}], 'secondaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '12 months post-operatively', 'description': "Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elbow', 'Upper Extremity Fractures', 'Distal Humerus', 'Elbow Injuries', 'Dislocations', 'Peri-articular Elbow Injuries'], 'conditions': ['Upper Extremity Fracture', 'Upper Extremity Dislocation', 'Fractures, Comminuted', 'Elbow Fracture', 'Elbow Dislocation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.', 'detailedDescription': "Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.\n\nWe intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.\n\nImprovement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.\n\nThe use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation\n* Agrees to participate and signs informed consent\n* English Speaking (outcome questionnaires are validated for English only)\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Closed Head Injury\n* Burn Injuries\n* Ipsilateral upper extremity fracture(s) requiring surgery\n* Nonunion of prior distal humerus fracture or fracture dislocation\n* Type 3 open distal humerus fracture dislocation\n* Insufficient fracture fixation to allow early range of motion\n* Transient population with no fixed address\n* Not willing to sign informed consent\n* Does not speak English'}, 'identificationModule': {'nctId': 'NCT00580866', 'acronym': 'JAS', 'briefTitle': 'Progressive Splinting Status Post Elbow Fractures and Dislocations', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations', 'orgStudyIdInfo': {'id': '051196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Joint Active Systems Brace (JAS Brace)', 'description': 'Elbow is placed in a brace to apply an extension force', 'interventionNames': ['Device: JAS Brace']}, {'type': 'NO_INTERVENTION', 'label': 'PT Only Group', 'description': 'No brace is used'}], 'interventions': [{'name': 'JAS Brace', 'type': 'DEVICE', 'otherNames': ['JAS Static Progressive Stretch', 'Joint Active Systems Brace (JAS Brace)', 'Static Stretching Brace', 'Static Progressive Stretching Brace'], 'description': 'For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.', 'armGroupLabels': ['Joint Active Systems Brace (JAS Brace)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-8774', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'William T Obremskey, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'William Obremskey', 'investigatorAffiliation': 'Vanderbilt University'}}}}