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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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Inselspital Bern
Bern, Switzerland
Dept. of Neurosurgery, Zurich University Hospital
Zurich, Switzerland
Start Date
January 1, 2015
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
May 14, 2024
88
ACTUAL participants
Reimplantation of cryoconserved bone flap
PROCEDURE
Lead Sponsor
University of Zurich
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06017635