Clinical trials: Skull Defect
E04.525.190, Craniotomy
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Trial name
- NCT01282645
- Testing
- PSI in PEEK
- Where
- 30 sites in Austria, Belgium and 13 more
- Sponsor
- Synthes GmbH
Multiple Sclerosis
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.
- Trial name
- MS-ON (NCT02220244)
- Testing
- MD1003 100mg capsule
- Where
- 20 sites in France, United Kingdom
- Volunteers
- 105 people
- Sponsor
- MedDay Pharmaceuticals SA
Zygomaticomaxillary Complex Fracture, Orbital Floor Fractures
Evaluating The Prebent Titanium Mesh for Zygomatico-Orbital Reconstruction in Twelve Patients Measuring Multiple Ophthalmologic Parameters, Aesthetic Results, Orbital Volume, Area of Bone Defect, Layout Angle, Gab Length and The Accuracy of Reconstruction
Purpose: The aim of this study was to evaluate the role of using a prebent titanium mesh on a 3D-printed model as an intraoperative guide to reconstruct orbito-zygomatic-maxillary complex (OZMC) fractures.
- Conditions
- Zygomaticomaxillary Complex Fracture, Orbital Floor Fractures, Ophthalmic Trauma
- Trial name
- NCT07103187
- Testing
- Zygomatico-Orbital reconstruction
- Where
- Egypt
- Volunteers
- 12 people
- Sponsor
- Tanta University
Cranial Defect
Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction
Background Cranial reconstruction after monocortical bonegraft harvesting remains a clinical challenge for the maxillofacial surgeon. At present, there is no gold standard technique advised.
- Trial name
- CRAN-PSI (NCT03841643)
- Testing
- patient-specific implant, cement
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- AZ Sint-Jan AV
Cranial Defect
Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
- Trial name
- FAST-ECP (NCT07183540)
- Testing
- operation opportunity-within 6 weeks after the DC operation., operation opportunity-within 90 to 180 days after the DC operation.
- Where
- 7 sites in China
- Volunteers
- 582 people
- Sponsor
- The Affiliated Hospital Of Guizhou Medical University
Brain Injuries, Hematoma of Head
Comparison of Cranioplasty With PEEK and Titanium
Decompressive craniectomy is suggested as an effective surgical intervention for patients with high intracranial pressure. Recently, various customized artificial materials are increasingly employed, e.g., titanium and…
- Conditions
- Brain Injuries, Hematoma of Head, Skull Defect
- Trial name
- NCT04707404
- Testing
- Cranioplasty
- Volunteers
- 100 people
- Sponsor
- RenJi Hospital
Skull Defect, Transplant Complication
Comparison of Clinical Value in the Use of the Fascia Lata and Temporal Muscle Fascia in the Reconstruction of the Dura in the Sellar Region
Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region Objective: The primary objective of this study is to investigate and compare the…
- Conditions
- Skull Defect, Transplant Complication, Quality of Life
- Trial name
- NCT06493812
- Testing
- Fascia lata, Temporal fascia
- Where
- Croatia
- Volunteers
- 68 people
- Sponsor
- Klinički Bolnički Centar Zagreb
Skull Defect
3D Printed PEEK Implants for Cranioplasty
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused…
- Trial name
- PEEKCP (NCT05291754)
- Testing
- PEEK Cranioplasty
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Skane University Hospital
Skull Base Pathology
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery
The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e.
- Trial name
- UPSIT (NCT02165969)
- Testing
- endoscopic endonasal surgery with UPSIT
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ricardo L. Carrau, MD
Stroke, Head Trauma
Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects
Patients with skull defects after craniotomy for example tumor resection, head trauma, stroke, need a reimplantation of the bone afterwards.
- Trial name
- CAPSID (NCT02828306)
- Testing
- Patient Specific Implant
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack
Diagnosis of ON With or Without MS or NMOSD
This is both a prospective and retrospective study of patients with a known diagnosis of optic neuritis (ON) only, multiple sclerosis (MS) with ON, or neuromyelitis spectrum disorder (NMOSD) with ON.
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack, Neuromyelitis Optica Spectrum Disorder Relapse, Neuromyelitis Optica Spectrum Disorder Progression
- Trial name
- NCT04131764
- Testing
- Reflex (Brightlamp Inc., Purdue University)
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Jagannadha R Avasarala
Nerve Fiber Bundle Defect, Optic Nerve Diseases
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.
- Trial name
- NCT01422525
- Testing
- spectral domain optical coherence tomography
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- University Eye Hospital, Würzburg
Mitochondrial Myopathies, Mitochondrial Pathology
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary…
- Conditions
- Mitochondrial Myopathies, Mitochondrial Pathology, Mitochondrial DNA Mutation, Mitochondrial Diseases
- Trial name
- NuPower (NCT05162768)
- Testing
- Elamipretide
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Stealth BioTherapeutics Inc.
Cranial Bone Defect, Orbital Base Fracture
Clinical Study of FRC Implant to Treat Skull Bone Defects
Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects. Functional and aesthetic outcome is assessed by patient and doctor.
- Trial name
- Cranio-2 (NCT01874613)
- Testing
- FRC implant reconstruction
- Where
- Finland
- Volunteers
- 19 people
- Sponsor
- Turku University Hospital
Cranial Defect, TCD
A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of…
- Trial name
- NCT06642532
- Testing
- TCD group
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- RenJi Hospital
Cranioplasty, Disability Physical
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses.
- Conditions
- Cranioplasty, Disability Physical, Trauma
- Trial name
- Cranioplasty (NCT04111562)
- Testing
- Cranioplasty
- Where
- Egypt
- Volunteers
- 35 people
- Sponsor
- Assiut University
Craniosynostosis
Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in which the sutures between skull bones close too early, causing long-term problems with brain and skull growth.
- Trial name
- NCT03025763
- Testing
- Craniosynostosis Network Environmental Survey, 2D/3D Photography, Buccal Swab Cell Sampling
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 2,145 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Skull Defect
Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants
This project aims to develop an effective deep learning system to generate numerical implant geometry based on 3D defective skull models from CT scans.
- Trial name
- NCT05603949
- Testing
- 3D deep learning neural network system
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- Chang Gung Memorial Hospital
Skull Defect
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and…
- Trial name
- NCT05416684
- Where
- China
- Volunteers
- 358 people
- Sponsor
- RenJi Hospital
Mandibular Tumor
Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using AI
The Aim of the study is to evaluate Accuracy of automated mandibular defect reconstruction using Artificial intelligence and assessing impact on aesthetic and occlusion outcomes using patient-specific reconstruction plates.
- Trial name
- NCT06945692
- Testing
- patient specific reconstruction plates
- Volunteers
- 4 people
- Sponsor
- Cairo University