Clinical trials: Cranial Fixation
Craniotomy
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06780852
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- RevBio
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
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
Brain Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
Craniotomy
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06095531
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- RevBio
Cranial Bone, Post-operative Complications
Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than…
- Conditions
- Cranial Bone, Post-operative Complications, Cranial Fixation, Cranioplasty
- Trial name
- NCT07103330
- Testing
- Metallic fixation hardware, Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
- Volunteers
- 100 people
- Sponsor
- Abyrx, Inc.
Craniotomy
Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.
- Trial name
- NCT07452549
- Testing
- Tetranite for Cranial Flap Fixation, Standard of Care Plating System
- Volunteers
- 204 people
- Sponsor
- RevBio
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
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.