Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT00725894
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2008-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2008-07-29', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'limb alignment', 'timeFrame': '48 months'}], 'secondaryOutcomes': [{'measure': 'length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications', 'timeFrame': '48 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Femur Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject, representative willing to sign informed consent.\n2. Ability and willingness of the subject to follow postoperative care instructions until healing is complete\n3. Subject age must be between 8-16 inclusive.\n4. Subjects with a minimal canal diameter of 9mm or greater\n\nAnd any of the following fracture types\n\n1. Non-comminuted and comminuted mid-shaft fractures\n2. Distal third fractures 4 cm above the distal physis\n3. Fractures that are open or closed\n4. Subtrochanteric fractures\n\nExclusion Criteria:\n\n1. A subject has a bone or soft tissue infection.\n2. Subject has a systemic infection.\n3. Subject has a distal (supracondylar) fracture.\n4. Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).\n5. Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.\n6. Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.\n7. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.'}, 'identificationModule': {'nctId': 'NCT00725894', 'acronym': 'PLN', 'briefTitle': 'Pediatric Locking Nail for the Treatment of Femoral Fractures in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children', 'orgStudyIdInfo': {'id': 'CS-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children', 'interventionNames': ['Device: Pediatric Locking Nail']}], 'interventions': [{'name': 'Pediatric Locking Nail', 'type': 'DEVICE', 'description': 'The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Orthopedic Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Russell Schenck, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}