Clinical trials: Cranioplasty
Transcranial Ultrasound With Sonolucent Cranioplasty, TUSC
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires…
- Trial name
- TUSC MIS (NCT05538286)
- Testing
- ClearFit implant, transcranial ultrasonography through sonolucent cranioplasty
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Cerebral Decompression Injury, Cranioplasty
Controlled Study in Cranioplasty Reconstruction
Multicenter, prospective, comparative, observational study with regular follow-up visits. The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice…
- Trial name
- NCT01641523
- Testing
- CustomBone Service
- Volunteers
- 91 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
Decompressive Craniectomy and Cranioplasty
Predictive Factors for Cranioplasty Complications - A Decade Experience
This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies.
- Trial name
- NCT04791904
- Where
- Portugal
- Volunteers
- 168 people
- Sponsor
- Universidade do Porto
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.
Skull Defects, Cranioplasty
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or…
- Trial name
- NCT00923793
- Testing
- Titanium implant (CranioConstruct™), Hydroxylapatite (CustomBone)
- Where
- Germany
- Volunteers
- 53 people
- Sponsor
- University of Leipzig
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
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
Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties
This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative…
- Trial name
- NCT03667352
- Testing
- Unilateral Scalp Block, Transversus abdominis plane block, Intravenous Fentanyl
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Dhritiman Chakrabarti
Acquired Brain Injury, Traumatic Brain Injury
Connectivity in Cranioplasty
An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6…
- Conditions
- Acquired Brain Injury, Traumatic Brain Injury, Ischemic Stroke, Hemorrhagic Stroke
- Trial name
- NCT05440682
- Testing
- CP group
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Azienda Usl di Bologna
Cranioplasty, Craniofacial Abnormalities
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and…
- Conditions
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- Trial name
- NCT05362370
- Testing
- Stryker's PEEK Customized Implant
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 99 people
- Sponsor
- Stryker Craniomaxillofacial
Traumatic Brain Injury
Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery
To evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh.
- Trial name
- NCT03222297
- Testing
- early skull repair, late-stage skull repair
- Volunteers
- 86 people
- Sponsor
- Taihe Hospital
Surgically-Created Resection Cavity
Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
Formal study hypothesis: Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will result in the patient producing their own bone to fill the void which will reduce the risk of infection and…
- Trial name
- NCT01742260
- Testing
- Repair of cranial defects by tissue engineering
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- R.P.Herrmann
Cognitive Impairment, Brain Herniation
Cranioplasty Cognitive Outcome Study
This will be a multicenter prospective randomized study of adult patients with an acquired skull defect as a result of craniectomy and considered suitable for cranioplasty, i.e.
- Trial name
- NCT03791996
- Testing
- "Early" cranioplasty
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Kwong Wah Hospital
Trephined Syndrome, Sinking Skin Flap Syndrome
Prevalence of Trephined Syndrome After Decompressive Craniectomy
Decompressive craniectomy is frequently used to treat increased intracranial pressure or an intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is attributed to a large craniectomy.
- Conditions
- Trephined Syndrome, Sinking Skin Flap Syndrome, Traumatic Brain Injury, Stroke
- Trial name
- TS (NCT03186157)
- Testing
- Decompressive craniectomy, Cranioplasty
- Where
- Switzerland
- Volunteers
- 41 people
- Sponsor
- University Hospital, Geneva
Head Injuries, Subarachnoid Haemorrhage
Impact of Cranioplasty On Cerebral Perfusion
The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head injuries, Subarachnoid haemorrhage…
- Conditions
- Head Injuries, Subarachnoid Haemorrhage, Intra-cerebral Haemorrhage, Cerebral Thrombosis
- Trial name
- CCP (NCT01113645)
- Testing
- Cerebral perfusion evaluation
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty
A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.
A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and…
- Trial name
- NCT06201429
- Testing
- Mechanical Tissue Resuscitation™ (MTR®)
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Renovo Concepts, Inc.
Surgical Procedure, Unspecified
Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft
Elevated intracranial pressure (ICP) is a common neurosurgical emergency that may arise from several conditions, which cause an intracranial mass effect.
- Trial name
- NCT04855175
- Testing
- Synthetic Bone Allograft (ClearFit), Autograft
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- LifeBridge Health
Cranium; Deformity
Synthetic Cranioplasty PEEK Versus UHMWP
The purpose of this study is to report the investigators experience with synthetic reconstruction of cranial defects using computer guided milled UHMWP, in terms of benefits and limitations both clinically and radiographically in…
- Trial name
- NCT05250024
- Testing
- UHMWP Cranioplasty, PEEK Cranioplasty
- Where
- Egypt
- Volunteers
- 22 people
- Sponsor
- Cairo University
Cranial Defects
Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty
The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty.
- Trial name
- NCT06782711
- Testing
- cranioplasty, customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- CIMET SCIENTIFIC CORPORATION