Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05291754 |
| Other study ID # |
Ver1.2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2021 |
| Est. completion date |
November 26, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Skane University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 filament fabrication 3D printer. The
primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to
compare complication rates with conventional methods such as autologous bone and
polymethylmetacrylate (PMMA).
Description:
Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma,
infection or decompressive craniectomy. Although some patients can tolerate cranial defects
for varied periods of time, cranioplasty is mostly indicated due to the increased risk of
additional brain trauma, local pain or impaired CSF circulation but also aesthetic and
psychological issues. The gold standard for repair since many years is cranioplasty with
autologous bones . However, sometimes it not feasible to use the patient's autologous bone
due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the
autologous bone grafts several different materials have been used, or are in use, as titanium
meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous
polyethylene. Some of these have gathered increased interest due to advancements in
technology for manufacture of these materials, and also the possibility to create custom made
implants or moulds.
The present study aims to assay safety and feasibility of in house 3D printed medical grade
PEEK implants in research persons with acquired skull defects.
The implants will be manufactured after 3D rendering from CT images of the skull defects,
sterilised and aseptically inserted in the defects by means of a surgical intervention.
A safety interim analysis will be performed after inclusion of 10 patients.
