Brain Edema
Conditions
Keywords
autologous bone flap, decompressive craniectomy, malignant brain swelling, patient specific implant, bone resorption, aseptic bone necrosis
Brief summary
The complications after reimplantation of cryoconserved autologous bone flaps are reported inhomogeniously in the literature. Especially the incidence of bone flap resorption varies from 0% to about 30%. More recent retrospective studies seem to find higher resorption rates and thus suggest to implant artificial bone replacements from the start. The Swiss Prospective Autologous bone Resorption Study is the first propspective observational study designed to determine the true incidence of autologous bone resorption.
Detailed description
Patients undergoing decompressive craniectomy and delayed reimplantation of the cryoconserved autologous bone flap are included in a clinical and image-based follow-up to identify cases and severity of bone flap resorption. The explanted autologous bone flaps are cryoconserved and reimplanted at a time-point defined by the surgeon according to standards of the participating hospital. The fixation of the bone flap is also performed according to the surgeon's decision. A cranial CT is performed within one week after reimplantation to define a baseline. A second, only clinical, follow-up will take place within 2 months after reimplantation. Two more follow-ups including photodocumentation of the cranial and facial symmetry (portrait and profile) and cranial CT will take place 12 and 24 months after reimplantation. The indication for surgical revision in case of bone flap resorption is independent from the study and falls under the responsibility of the treating surgeon.
Interventions
PROCEDUREReimplantation of cryoconserved bone flap
A bone flap, which was explanted for decompression of a swollen brain or following severe head trauma and which was cryoconserved in the meantime is reimplanted. This procedure is the gold-standard therapy after decompressive hemicraniectomy and is routinely performed.
Sponsors
University of Zurich
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* all patients after hemicraniectomy or bifrontal craniectomy * age 18-99 y/o * ability to understand and sign informed consent (alternatively, legal representative may sign)
Exclusion criteria
* bone flap not fit for reimplantation * no cryoconservation performed but other technique * pregnancy * patient's death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a relevant bone resorption within 12 months after reimplantation | 12 months | The extent of bone flap resorption is analyzed as well objectivela as subjectivels: objective criteria: Volumetric reconstruction of the bone flap from the CT scans and subtration of the actual bone flap volume from the 3D model at the basline-timepoint directly after reimplantation subjective: a bone flap resorption score is validated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 2, 12 and 24 months after reimplantation | death |
| Infections | 2, 12 and 24 months after reimplantation | Infections |
| Fluid collections and bleedings | 2, 12 and 24 months after reimplantation | subgaleal, epidural and subdural fluid collections and hematomas |
| Hydrocephalus | 2, 12 and 24 months after reimplantation | hydrocephalus |
| Temporal muscle atrophy | 2, 12 and 24 months after reimplantation | temporal muscle atrophy |
| Incidence of an indication for surgical revision | 12 and 24 months after reimplantation | The indication for a surgical revision falls under responsibility of the treating surgeon. |
| patient age | 2, 12 and 24 months after reimplantation | in years |
| fragmentation of the bone flap | 2, 12 and 24 months after reimplantation | in number of pieces |
| temperature used for cryoconservation | 2, 12 and 24 months after reimplantation | in °C |
| pathologies leading to explantation of the bone flap (hemicraniectomy) | 2, 12 and 24 months after reimplantation | trauma, tumor, stroke and others |
| timepoint between explantation and reimplantation | 2, 12 and 24 months after reimplantation | measured in months |
Countries
Switzerland
Outcome results
None listed