Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 4:39 AM
Study NCT ID:
NCT01589692
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D016267', 'term': 'External Fixators'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Demographics', 'timeFrame': 'baseline', 'description': 'Participant age, income, education level, race/ethnicity'}, {'measure': 'Comorbidities', 'timeFrame': 'baseline', 'description': 'Self-Administered Comorbidity Checklist'}, {'measure': 'Therapy compliance', 'timeFrame': '12months', 'description': 'count of therapy sessions and description of therapy type'}], 'primaryOutcomes': [{'measure': 'Michigan Hand Outcomes Questionnaire score', 'timeFrame': '12months', 'description': 'upper-extremity questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in Rapid Assessment of Physical Activity score', 'timeFrame': 'pre-injury and 24months', 'description': 'questionnaire'}, {'measure': 'SF-36 score', 'timeFrame': '12months', 'description': 'QOL questionnaire'}, {'measure': 'complications', 'timeFrame': '12months', 'description': 'Complication Checklist for Distal Radius Fracture'}, {'measure': 'Hand function', 'timeFrame': '12months', 'description': 'grip strength, lateral pinch strength, wrist motion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WRIST', 'Distal Radius Fracture', 'DRF', 'elderly', 'internal fixation', 'VLPS', 'External Fixation', 'Multi center randomized trial'], 'conditions': ['Distal Radius Fracture']}, 'referencesModule': {'references': [{'pmid': '20375760', 'type': 'BACKGROUND', 'citation': 'Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-523. doi: 10.1097/PRS.0b013e3181df64fa.'}, {'pmid': '23608306', 'type': 'BACKGROUND', 'citation': 'Wrist and Radius Injury Surgical Trial (WRIST) Study Group. Reflections 1 year into the 21-Center National Institutes of Health--funded WRIST study: a primer on conducting a multicenter clinical trial. J Hand Surg Am. 2013 Jun;38(6):1194-201. doi: 10.1016/j.jhsa.2013.02.027. Epub 2013 Apr 20.'}, {'pmid': '36780156', 'type': 'DERIVED', 'citation': 'Jayaram M, Wu H, Yoon AP, Kane RL, Wang L, Chung KC. Comparison of Distal Radius Fracture Outcomes in Older Adults Stratified by Chronologic vs Physiologic Age Managed With Casting vs Surgery. JAMA Netw Open. 2023 Feb 1;6(2):e2255786. doi: 10.1001/jamanetworkopen.2022.55786.'}, {'pmid': '34142664', 'type': 'DERIVED', 'citation': 'Yoon AP, Wang Y, Wang L, Chung KC; and the WRIST Group. What Are the Tradeoffs in Outcomes after Casting Versus Surgery for Closed Extraarticular Distal Radius Fractures in Older Patients? A Statistical Learning Model. Clin Orthop Relat Res. 2021 Dec 1;479(12):2691-2700. doi: 10.1097/CORR.0000000000001865.'}, {'pmid': '34137830', 'type': 'DERIVED', 'citation': 'Chung KC, Kim HM, Malay S, Shauver MJ; WRIST Group. Comparison of 24-Month Outcomes After Treatment for Distal Radius Fracture: The WRIST Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112710. doi: 10.1001/jamanetworkopen.2021.12710.'}, {'pmid': '33337492', 'type': 'DERIVED', 'citation': 'Yoon AP, Wang C, Speth KA, Wang L, Chung KC; WRIST Group. Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028929. doi: 10.1001/jamanetworkopen.2020.28929.'}, {'pmid': '32433648', 'type': 'DERIVED', 'citation': 'Hooper RC, Zhou N, Wang L, Shauver MJ, Chung KC; WRIST Group. Pre-injury activity predicts outcomes following distal radius fractures in patients age 60 and older. PLoS One. 2020 May 20;15(5):e0232684. doi: 10.1371/journal.pone.0232684. eCollection 2020.'}, {'pmid': '31951273', 'type': 'DERIVED', 'citation': 'Chung KC, Cho HE, Kim Y, Kim HM, Shauver MJ; WRIST Group. Assessment of Anatomic Restoration of Distal Radius Fractures Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919433. doi: 10.1001/jamanetworkopen.2019.19433.'}, {'pmid': '30657531', 'type': 'DERIVED', 'citation': 'Chung KC, Malay S, Shauver MJ, Kim HM; WRIST Group. Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older: A Secondary Analysis of the WRIST Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187053. doi: 10.1001/jamanetworkopen.2018.7053.'}, {'pmid': '29952895', 'type': 'DERIVED', 'citation': 'Nasser JS, Huetteman HE, Shauver MJ, Chung KC. Older Patient Preferences for Internal Fixation after a Distal Radius Fracture: A Qualitative Study from the Wrist and Radius Injury Surgical Trial. Plast Reconstr Surg. 2018 Jul;142(1):34e-41e. doi: 10.1097/PRS.0000000000004454.'}]}, 'descriptionModule': {'briefSummary': 'In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches.\n\nThe specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have an unstable DRF for which surgical fixation is indicated\n\n o AO type A2, A3, C1, C2\n* At least one of the following radiographic criteria indicating fracture instability\n\n * Dorsal angulation of greater than 10°\n * Radial inclination angle of less than 15°\n * Radial shortening of greater than 3mm\n* Patients with the ability to read and understand English (to complete study questionnaires)\n* Community-dwelling patients\n* Patients 60 years of age or older\n\nExclusion Criteria:\n\n* Patients who have suffered open DRFs\n* Patients with bilateral DRFs\n* Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation\n* Multi-trauma patients\n* Patients with prior DRF on the same wrist\n* Patients with comorbid conditions prohibiting surgery\n* Patients with neurologic disorders that affect hand, wrist or arm sensation or movement\n* Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders\n* Patients with current substance abuse\n* Patients who do not agree to be randomized\n* Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)"}, 'identificationModule': {'nctId': 'NCT01589692', 'acronym': 'WRIST', 'briefTitle': 'A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)', 'orgStudyIdInfo': {'id': 'R01AR062066-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AR062066-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01AR062066-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AR062066-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internal Fixation', 'description': 'Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system', 'interventionNames': ['Procedure: Open Reduction and Internal Fixation']}, {'type': 'EXPERIMENTAL', 'label': 'External Fixation', 'description': 'External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.', 'interventionNames': ['Procedure: External Fixation']}, {'type': 'EXPERIMENTAL', 'label': 'Pinning', 'description': 'Percutaneous pinning with any number of Kirschner wires', 'interventionNames': ['Procedure: Percutaneous Pinning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Surgery', 'description': 'Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint', 'interventionNames': ['Procedure: Closed Reduction and casting']}], 'interventions': [{'name': 'Open Reduction and Internal Fixation', 'type': 'PROCEDURE', 'description': 'Internal fixation with a volar locking plating system', 'armGroupLabels': ['Internal Fixation']}, {'name': 'External Fixation', 'type': 'PROCEDURE', 'description': 'External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.', 'armGroupLabels': ['External Fixation']}, {'name': 'Percutaneous Pinning', 'type': 'PROCEDURE', 'description': 'Pinning with any number of Kirschner wires', 'armGroupLabels': ['Pinning']}, {'name': 'Closed Reduction and casting', 'type': 'PROCEDURE', 'description': 'Closed reduction and immobilization with a cast and/or splint', 'armGroupLabels': ['No Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '20114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Institute for Education and Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore - Long Island Jewish Health System', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kettering Health Network', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The MetroHealth System', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73126', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V3L 3W7', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Health Authority', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Kevin C Chung, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Charles B. G. de Nancrede Professor of Surgery', 'investigatorFullName': 'Dr. Kevin C. Chung', 'investigatorAffiliation': 'University of Michigan'}}}}