An observational study in Brain Edema, sponsored by University of Zurich. Terminated at 2 sites in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by University of Zurich · Observational
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.
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.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's enrollment of 88 is close to the median of 88 across 31 observational studies indexed under Brain Edema.
Browse Brain Edema studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients who receive reimplantation of a cryoconserved autologous bone flap
Procedure: Reimplantation 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.
Incidence of a relevant bone resorption within 12 months after reimplantation
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
Time frame: 12 months
Incidence of an indication for surgical revision
The indication for a surgical revision falls under responsibility of the treating surgeon.
Time frame: 12 and 24 months after reimplantation
Death
death
Time frame: 2, 12 and 24 months after reimplantation
Infections
Infections
Time frame: 2, 12 and 24 months after reimplantation
Fluid collections and bleedings
subgaleal, epidural and subdural fluid collections and hematomas
Time frame: 2, 12 and 24 months after reimplantation
Hydrocephalus
hydrocephalus
Time frame: 2, 12 and 24 months after reimplantation
Temporal muscle atrophy
temporal muscle atrophy
Time frame: 2, 12 and 24 months after reimplantation
timepoint between explantation and reimplantation
measured in months
Time frame: 2, 12 and 24 months after reimplantation
patient age
in years
Time frame: 2, 12 and 24 months after reimplantation
fragmentation of the bone flap
in number of pieces
Time frame: 2, 12 and 24 months after reimplantation
temperature used for cryoconservation
in °C
Time frame: 2, 12 and 24 months after reimplantation
pathologies leading to explantation of the bone flap (hemicraniectomy)
trauma, tumor, stroke and others
Time frame: 2, 12 and 24 months after reimplantation
The record gives a start of Jan 2015, a primary completion of Dec 2023 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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