Swiss Prospective Autologous Bone Flap Resorption Study (SPARS)

University of Zurich (UZH)

Status: Terminated

Conditions: Brain Edema

Treatments: Procedure: Reimplantation of cryoconserved bone flap

Study type: Observational

Funder types: Other

Identifiers

NCT02320955

ZH-2014-0370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 1 patient group

Reimplantation of cryoconserved bone flap

Description:

All patients who receive reimplantation of a cryoconserved autologous bone flap

Treatment:

Procedure: Reimplantation of cryoconserved bone flap