Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT00908895
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephane.pelet.ortho@gmail.com', 'phone': '418-649-0252', 'title': 'Dr Stéphane Pelet, MD, PhD', 'phoneExt': '3165', 'organization': "Département d'orthopédie, CHA-Pavillon Enfant-Jésus Québec"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Very long time between the end of the study and the manuscript preparation due to temporarily lack of statistician and the need for some national associations that the study is not published before presentation.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Radio-radial Fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Percutaneous Pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radio-radial Fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)'}, {'id': 'OG001', 'title': 'Percutaneous Pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '103.9'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '56.1', 'upperLimit': '68.9'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '70', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25', 'groupDescription': 'We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.', 'unitOfMeasure': 'Percentage of opposite side', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No participant changed to the other group. Patients lost or with complications were not analyzed'}, {'type': 'SECONDARY', 'title': 'Range of Movement of Wrist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radio-radial Fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)'}, {'id': 'OG001', 'title': 'Percutaneous Pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks'}], 'classes': [{'title': 'Dorsal flexion', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '96.9'}, {'value': '81.7', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '85.6'}]}]}, {'title': 'Volar flexion', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '96.6'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '69.5', 'upperLimit': '79.9'}]}]}, {'title': 'Pronation', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.3'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '92.8'}]}]}, {'title': 'Supination', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '93.5'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '84.1'}]}]}, {'title': 'Radial inclination', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '95.3'}, {'value': '71.1', 'groupId': 'OG001', 'lowerLimit': '64.9', 'upperLimit': '77.3'}]}]}, {'title': 'Cubital inclination', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '89.1', 'upperLimit': '98.9'}, {'value': '65.6', 'groupId': 'OG001', 'lowerLimit': '57.7', 'upperLimit': '73.5'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '90', 'ciLowerLimit': '80', 'ciUpperLimit': '100', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.\n\nMotion is described as a percentage of the opposite side.', 'unitOfMeasure': 'Percentage of opposite side', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radio-radial Fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)'}, {'id': 'FG001', 'title': 'Percutaneous Pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'algodystrophy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment started in April of 2003 and finished in June of 2006.', 'preAssignmentDetails': "Only surgical fractures were addressed to the research team, after prior selection by orthopedic surgeon. So we didn't see all radius fractures in the department."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Radio-radial Fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)'}, {'id': 'BG001', 'title': 'Percutaneous Pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast 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': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '19', 'groupId': 'BG000'}, {'value': '54', 'spread': '16', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-25', 'studyFirstSubmitDate': '2009-05-26', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-12', 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Grip Strength', 'timeFrame': '6 months', 'description': 'Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.'}], 'secondaryOutcomes': [{'measure': 'Range of Movement of Wrist', 'timeFrame': '6 months', 'description': 'Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.\n\nMotion is described as a percentage of the opposite side.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radius fractures', 'Radio-radial fixator', 'Percutaneous pinning', 'Grip strength'], 'conditions': ['Radius Fractures']}, 'descriptionModule': {'briefSummary': 'The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.\n\nThe purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Distal radius fracture Frykman I or II\n* Unstable fracture according to Lafontaine's criteria\n* Fracture line more than 1cm form the joint line\n* Closed fracture\n* Age \\> 18 years\n* Surgery performed between 72 hours from the trauma\n* Monotrauma\n* Patient signed the informed consent\n\nExclusion Criteria:\n\n* Distal radius fracture Frykman III-VI (intra-articular fracture)\n* Open fracture\n* Polytraumatism\n* Stable or non-displaced fracture"}, 'identificationModule': {'nctId': 'NCT00908895', 'briefTitle': 'Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': "Hopital de l'Enfant-Jesus"}, 'officialTitle': 'Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'PEJ-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radio-radial fixator', 'description': 'Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)', 'interventionNames': ['Procedure: Radio-radial fixator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous pinning', 'description': 'Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks', 'interventionNames': ['Procedure: Percutaneous pinning']}], 'interventions': [{'name': 'Radio-radial fixator', 'type': 'PROCEDURE', 'description': 'Using the Distal Radius Fixator from Synthes. A single splint for 5 days.', 'armGroupLabels': ['Radio-radial fixator']}, {'name': 'Percutaneous pinning', 'type': 'PROCEDURE', 'description': 'Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.', 'armGroupLabels': ['Percutaneous pinning']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1J1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Département d'orthopédie, CHA-Pavillon Enfant-Jésus", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hopital de l'Enfant-Jesus", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pelet Stéphane, MD, PhD', 'oldOrganization': "Hopital de l'Enfant-Jésus"}}}}