Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05703958
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2023-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D005599', 'term': 'Fractures, Ununited'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2034-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smart Score', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score'}, {'measure': 'Sane Score', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal'}, {'measure': 'ASES', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition'}, {'measure': 'Quick DASH', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Humeral Fracture', 'Fracture Dislocation', 'Non-Union Fracture']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing ORIF surgery who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing to agree to be followed for up to 10 years following their index surgery\n* Patient is willing and able to review and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient has a physical or mental condition that would invalidate the results"}, 'identificationModule': {'nctId': 'NCT05703958', 'briefTitle': 'Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exactech'}, 'officialTitle': 'An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes', 'orgStudyIdInfo': {'id': 'CR21-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '718-206-6923'}], 'facility': 'NYU Grossman School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Rachael Craig', 'role': 'CONTACT', 'email': 'rachael.craig@exac.com', 'phone': '352-377-1140'}, {'name': 'Sandrine Angibaud', 'role': 'CONTACT', 'email': 'sandrine.angbaud@exac.com', 'phone': '352-377-1140'}], 'overallOfficials': [{'name': 'Abhishek Ganta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exactech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}