Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT03259906
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Lack of performance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of functional recovery using the DASH questionnaire', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Intra-articular Radius Fracture With a Dorsal Tilt']}, 'descriptionModule': {'briefSummary': 'For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.\n\nFirst-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.\n\nIn the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided written informed consent\n* Patients older than 45 years\n* Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)\n\nExclusion Criteria:\n\n* Adults under guardianship\n* Patients without national health insurance cover\n* Pregnant or breast-feeding women\n* Patients presenting other injuries in the same upper limb\n* Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)\n* Pre-trauma paralysis of the limb\n* Open fracture\n* Fracture with palmer tilt or extra-articular'}, 'identificationModule': {'nctId': 'NCT03259906', 'acronym': 'PAPPO', 'briefTitle': 'Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate', 'orgStudyIdInfo': {'id': 'ALVERNHE LABATTUT 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Osteosynthesis using a posterior plate', 'interventionNames': ['Other: DASH score', 'Procedure: X-ray', 'Procedure: posterior osteosynthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Osteosynthesis using an anterior plate', 'interventionNames': ['Other: DASH score', 'Procedure: X-ray', 'Procedure: Anterior osteosynthesis']}], 'interventions': [{'name': 'DASH score', 'type': 'OTHER', 'description': 'Questionnaire asking about Disability of Arm, Shoulder and Hand', 'armGroupLabels': ['Osteosynthesis using a posterior plate', 'Osteosynthesis using an anterior plate']}, {'name': 'X-ray', 'type': 'PROCEDURE', 'description': 'postoperative x-rays at 6 weeks, 3, 6 and 12 months', 'armGroupLabels': ['Osteosynthesis using a posterior plate', 'Osteosynthesis using an anterior plate']}, {'name': 'posterior osteosynthesis', 'type': 'PROCEDURE', 'description': 'Osteosynthesis using a posterior plate', 'armGroupLabels': ['Osteosynthesis using a posterior plate']}, {'name': 'Anterior osteosynthesis', 'type': 'PROCEDURE', 'description': 'Osteosynthesis using an anterior plate', 'armGroupLabels': ['Osteosynthesis using an anterior plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}