Swiss Prospective Autologous Bone Flap Resorption Study

Brain Edema Clinical Trial

— SPARS  

Official title:

Swiss Prospective Autologous Bone Flap Resorption Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02320955
• Other study ID #: ZH-2014-0370
• Status: Terminated
• Start date: January 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Inselspital Bern	Bern
Switzerland	Dept. of Neurosurgery, Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Incidence of an indication for surgical revision	The indication for a surgical revision falls under responsibility of the treating surgeon.	12 and 24 months after reimplantation
Secondary	Death	death	2, 12 and 24 months after reimplantation
Secondary	Infections	Infections	2, 12 and 24 months after reimplantation
Secondary	Fluid collections and bleedings	subgaleal, epidural and subdural fluid collections and hematomas	2, 12 and 24 months after reimplantation
Secondary	Hydrocephalus	hydrocephalus	2, 12 and 24 months after reimplantation
Secondary	Temporal muscle atrophy	temporal muscle atrophy	2, 12 and 24 months after reimplantation
Secondary	timepoint between explantation and reimplantation	measured in months	2, 12 and 24 months after reimplantation
Secondary	patient age	in years	2, 12 and 24 months after reimplantation
Secondary	fragmentation of the bone flap	in number of pieces	2, 12 and 24 months after reimplantation
Secondary	temperature used for cryoconservation	in °C	2, 12 and 24 months after reimplantation
Secondary	pathologies leading to explantation of the bone flap (hemicraniectomy)	trauma, tumor, stroke and others	2, 12 and 24 months after reimplantation