Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT04094935
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screws exceeding the posterior cortical', 'timeFrame': '3 months', 'description': 'Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.'}], 'secondaryOutcomes': [{'measure': 'Tendon complications', 'timeFrame': '3 months', 'description': 'Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.'}, {'measure': 'Secondary displacement or dismantling', 'timeFrame': '3 months', 'description': "Proportion of secondary displacement or dismantling 3-month control radio equipment (change of the radial slope on the face and radial glene's anversion on the profile between X-rays at J0 and control x-rays)"}, {'measure': 'Ablation of material or resumption early surgery', 'timeFrame': '3 months', 'description': 'Proportion of ablation of material or resumption early surgery on secondary displacement rated at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fracture of the radius'], 'conditions': ['Fracture; Radius, Lower or Distal End']}, 'descriptionModule': {'briefSummary': 'Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.\n\nThe intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)', 'detailedDescription': "* Preoperative consultation\n\n * Oral information of the patient of the protocol and delivery of the written information note\n * Seeking patient's non-opposition to participating in the study\n * Inclusion of the patient\n* Surgical procedure for distal radius fracture + immediate post-operative radiography\n\n * Intervention performed according to the usual practices of the service by the surgeon of the day without randomization\n * Radiography: 2 shots: face and wrist profile\n* Control X-ray + consultation\n\n * Achieved at 3 weeks, 6 weeks and 3 months after the intervention\n * X-rays: 2 shots: face and wrist profile\n* Control ultrasound o Realized at 3 months after the intervention\n\nEnd of participation in the study after consultation of 3 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients operated on for a fractured distal radius with an anterior locked plate in orthopaedic and trauma surgery in Saint Antoine Hospital, Paris', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane\n* Osteosynthesis by anterior locked plate\n* Patient who did not oppose his participation in this research\n\nExclusion Criteria:\n\n* Distal radius fractures with joint refend frontal (posterior marginal)'}, 'identificationModule': {'nctId': 'NCT04094935', 'acronym': 'SHORT', 'briefTitle': 'Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability', 'orgStudyIdInfo': {'id': 'APHP 190158'}, 'secondaryIdInfos': [{'id': '2019-A00429-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'olivier HERISSON, Doctor', 'role': 'CONTACT', 'email': 'olivierherisson@hotmail.com'}, {'name': 'Marc SOUBEYRAND, Pr', 'role': 'CONTACT', 'email': 'marc.soubeyrand@aphp.fr'}], 'facility': 'St Antoine hospital - orthopaedic and traumatic surgery', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Olivier HERISSON, Dr', 'role': 'CONTACT', 'email': 'olivierherisson@hotmail.com'}, {'name': 'Marc SOUBEYRAND, Pr', 'role': 'CONTACT', 'email': 'marc.soubeyrand@aphp.fr'}], 'overallOfficials': [{'name': 'Olivier HERISSON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}