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TerminatedNo phase

Swiss Prospective Autologous Bone Flap Resorption Study

Key facts

Who runs it
University of Zurich
Where
Switzerland2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
People taking part
88 people enrolled
Started
Jan 2015
Ended
31 Dec 2023
Type of study
Observational
Treatments tested
  • Reimplantation of cryoconserved bone flap
Record updated
14 May 2024
Why it stopped
Interim analysis confirmed too high rate of bone flap resorption. Continuation of the study was deemed unethical. Available data allow evaluation with sufficient power.

Who can take part

Age
18 years to 99 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • all patients after hemicraniectomy or bifrontal craniectomy
  • age 18-99 y/o
  • ability to understand and sign informed consent (alternatively, legal representative may sign)

Who cannot take part

  • bone flap not fit for reimplantation
  • no cryoconservation performed but other technique
  • pregnancy
  • patient's death

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • Reimplantation of cryoconserved bone flap

    All patients who receive reimplantation of a cryoconserved autologous bone flap

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
14 May 2024