Clinical trials: Skull Fractures
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Maxillofacial Bone Defects, Alveolar Bone Atrophy
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area.
- Conditions
- Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures, Maxillofacial Bone Deformities
- Trial name
- NCT02293031
- Testing
- Gene-activated matrix "Nucleostim"
- Where
- 2 sites in Russia
- Volunteers
- 12 people
- Sponsor
- NextGen Company Limited
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Mandibular Fractures, Mandible Fracture
Facial iD Customized Mandible Reconstruction Plates
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction.
- Conditions
- Mandibular Fractures, Mandible Fracture, Mandible; Deformity, MANDIBLE
- Trial name
- NCT07245758
- Testing
- Mandibular reconstruction
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Stryker Craniomaxillofacial
Zygomatic Fractures, Orbital Fractures
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting.
- Conditions
- Zygomatic Fractures, Orbital Fractures, Maxilla Fractures, Facial Fractures
- Trial name
- UMF (NCT07245719)
- Testing
- Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stryker Craniomaxillofacial
Tumor, Facial Fracture
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
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.
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia
- Trial name
- NCT04931056
- Testing
- Titanium Facial Plates, Titanium Mandibular Plates, Add-on Condyle
- Where
- Argentina
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
BoneTape Feasibility Trial
This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, specifically in the zygomaticomaxillary (midface) region.
- Conditions
- Zygomaticomaxillary Complex Fracture, Zygomatic Fractures, Zygoma Fracture
- Trial name
- NCT06600854
- Testing
- BoneTape
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Cohesys Inc.
Mandibular Fractures
A Cohort Study for Clinical Evaluation of OmniMax MMF System
OmniMax MMF system was designed as a device with faster application/removal time, less mucosal tissue overgrowth over the plates and screws, better tolerance for placement over prolong periods of time, better patient hygiene and…
- Trial name
- OmniMax (NCT03075865)
- Testing
- OmniMax MMF system
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zimmer Biomet
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Mandible Fracture, Mandibular Reconstruction
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting…
- Trial name
- SMRP (NCT07221916)
- Testing
- Mandibular Reconstruction
- Where
- 2 sites in United States, Germany
- Volunteers
- 70 people
- Sponsor
- Stryker Craniomaxillofacial