Swiss Prospective Autologous Bone Flap Resorption Study

N/ATerminatedNCT02320955

University of Zurich88 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Edema

Interventions

Reimplantation of cryoconserved bone flapPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (2)

Inselspital Bern

Bern, Switzerland

Dept. of Neurosurgery, Zurich University Hospital

Zurich, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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