Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04931056
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008337', 'term': 'Mandibular Fractures'}, {'id': 'D005357', 'term': 'Fibrous Dysplasia of Bone'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D006053', 'term': 'Goldenhar Syndrome'}, {'id': 'D008342', 'term': 'Mandibulofacial Dysostosis'}, {'id': 'C537680', 'term': 'Genee-Wiedemann syndrome'}, {'id': 'C538184', 'term': 'Acrofacial dysostosis, Nager type'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003394', 'term': 'Craniofacial Dysostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003103', 'term': 'Coloboma'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of implant at 1 year post operative', 'timeFrame': '1 year', 'description': 'Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal'}], 'secondaryOutcomes': [{'measure': 'Infection rate at 30 days post operative', 'timeFrame': '30 days', 'description': 'Implant site infection rate'}, {'measure': 'Allergic reaction related to implant material', 'timeFrame': 'up to 2 years', 'description': 'Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['facial plates', 'mandibular reconstruction', 'facial reconstruction', 'condylar tumor', 'orofacial cleft'], 'conditions': ['Tumor', 'Facial Fracture', 'Mandibular Fractures', 'Fibrous Dysplasia', 'Osteoma of Mandibular Condyle', 'Neuroma', 'Cleft Face', 'Hemifacial Microsomia', 'Treacher Collins Syndrome', 'Miller Syndrome', 'Nager Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.', 'detailedDescription': 'The subject devices are:\n\n* plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures\n* plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects, who underwent a facial, orbital, or midface procedure and received plates, screws and/or mesh manufactured by Biomet Microfixation. All enrolled subjects will provide data from a retrospective chart review on outcomes of interest.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females\n2. A patient who underwent one or more of the following surgical procedures completed between January 1, 2015 and December 31, 2019, with plates, screws, and or meshes from the Biomet Microfixation Facial Plating System:\n\n * Repair of a facial fracture\n * Repair of a facial osteotomy\n * Reconstructive procedures of the facial skeleton\n * Revision procedures where other treatments or devices have failed\n3. Available follow-up data at least at 30 days' post-operative\n\nExclusion Criteria:\n\n1. Active or latent infection at the time of implantation\n2. Documented foreign body sensitivity\n3. Patients with limited blood supply, insufficient quantity or quality of bone (e.g., osteomalacia or a bone resorption condition such as Paget's disease, osteoporosis, bone metastasis)\n4. Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions"}, 'identificationModule': {'nctId': 'NCT04931056', 'briefTitle': 'A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Clinical Evaluation of Biomet Microfixation Devices Used in Facial & Mandibular Surgical Procedures. Facial Plating System, HTR PEKK (Midface) and Mandibular Plates: A Post Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': '0220-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Facial Plating', 'description': 'Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.', 'interventionNames': ['Device: Titanium Facial Plates']}, {'label': 'Mandibular Plating', 'description': 'Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.', 'interventionNames': ['Device: Titanium Mandibular Plates', 'Device: Add-on Condyle']}, {'label': 'HTR-PEKK (midface)', 'description': 'Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.', 'interventionNames': ['Device: HTR-PEKK']}], 'interventions': [{'name': 'Titanium Facial Plates', 'type': 'DEVICE', 'otherNames': ['Titanium facial mini plates'], 'description': 'The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136.', 'armGroupLabels': ['Facial Plating']}, {'name': 'Titanium Mandibular Plates', 'type': 'DEVICE', 'otherNames': ['Titanium mandibular mini plates'], 'description': 'The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system.\n\nPlates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length.', 'armGroupLabels': ['Mandibular Plating']}, {'name': 'Add-on Condyle', 'type': 'DEVICE', 'description': 'The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease.', 'armGroupLabels': ['Mandibular Plating']}, {'name': 'HTR-PEKK', 'type': 'DEVICE', 'description': "The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone.", 'armGroupLabels': ['HTR-PEKK (midface)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salta', 'country': 'Argentina', 'facility': 'San Bernardo Hospital', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}], 'overallOfficials': [{'name': 'Mark Sun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}