Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-13 @ 4:17 PM
Study NCT ID:
NCT02066857
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D005543', 'term': 'Forearm Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CJarrett@wilmingtonhealth.com', 'phone': '404-778-8099', 'title': 'Claude Jarrett, M.D.', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A small number of participants was analyzed due to limited enrollment and completion rates.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collection for the duration of the study (2 years).', 'eventGroups': [{'id': 'EG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Wrist Range of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'id': 'OG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'timeFrame': 'Baseline, Month 3', 'description': 'Wrist ROM will be assessed by a goniometer exam.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure are not available for analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Mayo Wrist Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '31.67', 'spread': '16.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '46.67', 'spread': '20.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '65', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '78.33', 'spread': '2.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.'}, {'type': 'PRIMARY', 'title': 'Change in Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'id': 'OG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'timeFrame': 'Baseline, Month 3', 'description': 'Grip strength will be assessed by bilateral dynamometer testing.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure are not available for analysis.'}, {'type': 'PRIMARY', 'title': 'Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of Study (Up to 3 Months)', 'description': 'The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.'}, {'type': 'PRIMARY', 'title': 'Mean Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6', 'spread': '3.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '3.66', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '.33', 'spread': '.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.'}, {'type': 'SECONDARY', 'title': 'Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '73.03', 'spread': '23.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '38.63', 'spread': '27.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '23.33', 'spread': '22.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '11.67', 'spread': '16.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.'}, {'type': 'SECONDARY', 'title': 'Change in SF-12 QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'id': 'OG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'timeFrame': 'Baseline, Month 3', 'description': "The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.", 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'id': 'FG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Emory Orthopaedic Fracture Clinic from April 2014 to November 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Generic Plaster or Fiberglass Cast Group', 'description': 'Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'id': 'BG001', 'title': 'Generic "Off the Shelf" Removable Splint Group', 'description': 'Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.'}, {'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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2014-02-14', 'resultsFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-19', 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Wrist Range of Motion (ROM)', 'timeFrame': 'Baseline, Month 3', 'description': 'Wrist ROM will be assessed by a goniometer exam.'}, {'measure': 'Mean Mayo Wrist Score', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.'}, {'measure': 'Change in Grip Strength', 'timeFrame': 'Baseline, Month 3', 'description': 'Grip strength will be assessed by bilateral dynamometer testing.'}, {'measure': 'Complication Rate', 'timeFrame': 'Duration of Study (Up to 3 Months)', 'description': 'The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.'}, {'measure': 'Mean Pain Score', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.'}], 'secondaryOutcomes': [{'measure': 'Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score', 'timeFrame': 'Baseline, Week 2, Week 6, Week 12', 'description': 'The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.'}, {'measure': 'Change in SF-12 QOL', 'timeFrame': 'Baseline, Month 3', 'description': "The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wrist fracture', 'Radius fracture', 'Elderly', 'Splint', 'Cast'], 'conditions': ['Radius; Fracture, Lower or Distal End']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction\n2. Isolated upper limb injury\n3. No previous wrist fracture\n4. Available for follow-up\n5. Between 60 and 100 years of age\n\nExclusion Criteria:\n\n1. Less than 60 years of age\n2. Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit."}, 'identificationModule': {'nctId': 'NCT02066857', 'briefTitle': 'Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': 'IRB00071060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Generic plaster or fiberglass cast group', 'description': 'Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.', 'interventionNames': ['Device: Cast made of generic plaster or fiberglass cast material']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Generic "off the shelf" removable splint group', 'description': 'Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.', 'interventionNames': ['Device: Generic "off the shelf" removable splint']}], 'interventions': [{'name': 'Cast made of generic plaster or fiberglass cast material', 'type': 'DEVICE', 'otherNames': ['No brand name applicable.'], 'description': 'Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.', 'armGroupLabels': ['Generic plaster or fiberglass cast group']}, {'name': 'Generic "off the shelf" removable splint', 'type': 'DEVICE', 'otherNames': ['No brand name applicable'], 'description': 'Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.', 'armGroupLabels': ['Generic "off the shelf" removable splint group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Orthopaedics and Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Claudius Jarrett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopaedics', 'investigatorFullName': 'Claudius Jarrett', 'investigatorAffiliation': 'Emory University'}}}}