Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05179005
Status:
TERMINATED
Last Update Posted:
2024-01-29
First Post:
2021-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RibFix Advantage™ Post-Market Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor Terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall quality of life', 'timeFrame': 'Before surgery and 3 months post-op', 'description': 'American Chronic Pain Association Quality of Life scale'}, {'measure': 'Respiratory-related quality of life', 'timeFrame': '3 months post-op', 'description': 'Chronic Pulmonary Disease Assessment Test'}], 'primaryOutcomes': [{'measure': 'Rate of re-operation', 'timeFrame': '3 months post-op', 'description': 'Number of subjects who needed surgical re-intervention related to rib fracture repair'}], 'secondaryOutcomes': [{'measure': 'Length of stay in hospital', 'timeFrame': 'Day 0 (surgery) to Day 7', 'description': 'Time spent in hospital following surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Rib Fractures']}, 'referencesModule': {'references': [{'pmid': '11956391', 'type': 'BACKGROUND', 'citation': 'Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.'}, {'pmid': '17670487', 'type': 'BACKGROUND', 'citation': 'Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.'}, {'pmid': '16676852', 'type': 'BACKGROUND', 'citation': 'Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.'}, {'pmid': '19741406', 'type': 'BACKGROUND', 'citation': 'Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps--techniques and quality of life follow-up. J Trauma. 2009 Sep;67(3):596-601. doi: 10.1097/TA.0b013e3181ad8cb7.'}], 'seeAlsoLinks': [{'url': 'https://zbthoracic.com/rib-fixation/', 'label': 'Rib Trauma Solutions'}]}, 'descriptionModule': {'briefSummary': 'To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone', 'detailedDescription': 'Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thoracic trauma comprises 20-25% of all traumas worldwide and constitutes the third most common cause of death after abdominal injury and head trauma in polytrauma patients.\n\nThoracic trauma directly accounts for approximately 25% of trauma-related mortality and is a contributing factor in another 25% of such cases. The incidence of rib fractures due to trauma has been reported by various studies to range between 7 and 40%.\n\nThere is no standard treatment for rib fractures, though there are several options. Failure to treat rib fracture pain can lead to reduced movement, cough suppression, and secondary infection.\n\nThe conservative option for caring for a rib fracture involves the non-operative management of pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age, male or female\n* Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures\n* Minimum amount of follow-up data available, including one visit post-surgery\n* Willing and able to sign an Informed Consent for research\n* Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery\n\nExclusion Criteria:\n\n* Latent or active infection with positive culture at the time of implantation\n* Documented history of metal sensitivity\n* Documented psychiatric condition preventing the patient from following post-op care instructions\n* Fixation of the first and/or second (true) vertebrosternal rib\n* Bilateral rib fractures\n* Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization\n* Lung injury (open pneumothorax, tension pneumothorax, hemothorax \\> 1L, pulmonary contusion requiring mechanical ventilation)'}, 'identificationModule': {'nctId': 'NCT05179005', 'acronym': 'ZB-PIONEER', 'briefTitle': 'RibFix Advantage™ Post-Market Follow-Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™', 'orgStudyIdInfo': {'id': '0719-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RibFix Advantage', 'description': 'Underwent surgical stabilization of rib fractures', 'interventionNames': ['Device: RibFix Advantage']}], 'interventions': [{'name': 'RibFix Advantage', 'type': 'DEVICE', 'description': 'Intrathoracic rib fracture stabilization', 'armGroupLabels': ['RibFix Advantage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Health Surgery Services', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Christopher W Towe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Seidman Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}