Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT03328650
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2017-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Material Strength', 'timeFrame': 'During surgical procedure', 'description': 'Measured by the Osteoprobe'}, {'measure': 'Bone Indentation Distance', 'timeFrame': 'During surgical procedure', 'description': 'Measured by the Osteoprobe'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Humeral Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.\n\nSpecific Aims:\n\n* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs\n* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions\n* Document revisions, complications, and adverse events', 'detailedDescription': 'The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.\n\nSpecific Aims:\n\n* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs\n* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions\n* Document revisions, complications, and adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System\n* Patients who present with a proximal humerus fracture that involves the metaphysis\n* 18 years or older\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients who have an infection, sepsis, or osteomyelitis\n* Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support)\n* Patients who do not speak English (do to unavailability of non-English surveys)\n* Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)\n* Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years\n* Patients who have Type 1 diabetes\n* Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)\n* Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use"}, 'identificationModule': {'nctId': 'NCT03328650', 'acronym': 'ALPS PHP', 'briefTitle': 'Clinical Outcomes of the ALPS Proximal Humerus Plating System', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Clinical Outcomes of the ALPS Proximal Humerus Plating System', 'orgStudyIdInfo': {'id': '171043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Proximal Humerus Fracture Patients', 'description': "As part of their routine care, patients who have experienced a proximal humerus fracture that requires operative fixation will receive the A.L.P.S® Proximal Humerus Plating System. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes."}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie M Daniels', 'role': 'CONTACT', 'email': 'Julie.M.Daniels@Vanderbilt.edu', 'phone': '615-322-4506'}, {'name': 'Mihir J Desai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt Orthopaedics', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Julie M Daniels', 'role': 'CONTACT', 'email': 'Julie.M.Daniels@Vanderbilt.edu', 'phone': '615-322-4506'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopaedic Surgery and Rehabilitation', 'investigatorFullName': 'Mihir Desai', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}