Clinical trial NCT02320955: Swiss Prospective Autologous Bone Flap Resorption Study
Official title: Swiss Prospective Autologous Bone Flap Resorption Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Edema
Keywords: autologous bone flap
decompressive craniectomy
malignant brain swelling
patient specific implant
bone resorption
aseptic bone necrosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of a relevant bone resorption within 12 months after reimplantation
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of an indication for surgical revision
timeFrame: 12 and 24 months after reimplantation
measure: Death
timeFrame: 2, 12 and 24 months after reimplantation
measure: Infections
timeFrame: 2, 12 and 24 months after reimplantation
measure: Fluid collections and bleedings
timeFrame: 2, 12 and 24 months after reimplantation
measure: Hydrocephalus
timeFrame: 2, 12 and 24 months after reimplantation
measure: Temporal muscle atrophy
timeFrame: 2, 12 and 24 months after reimplantation
measure: timepoint between explantation and reimplantation
timeFrame: 2, 12 and 24 months after reimplantation
measure: patient age
timeFrame: 2, 12 and 24 months after reimplantation
measure: fragmentation of the bone flap
timeFrame: 2, 12 and 24 months after reimplantation
measure: temperature used for cryoconservation
timeFrame: 2, 12 and 24 months after reimplantation
measure: pathologies leading to explantation of the bone flap (hemicraniectomy)
timeFrame: 2, 12 and 24 months after reimplantation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zurich
country: Switzerland
facility: Dept. of Neurosurgery, Zurich University Hospital
Study officials:
References: