Swiss Prospective Autologous Bone Flap Resorption Study

NCT02320955 | Terminated

• 1 other identifier: ZH-2014-0370
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Brain Edema

Keywords

autologous bone flap; decompressive craniectomy; malignant brain swelling; patient specific implant; bone resorption; aseptic bone necrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Incidence of an indication for surgical revision

  12 and 24 months after reimplantation

• Death

  2, 12 and 24 months after reimplantation

• Infections

  2, 12 and 24 months after reimplantation

• Fluid collections and bleedings

  2, 12 and 24 months after reimplantation

• Hydrocephalus

  2, 12 and 24 months after reimplantation

Study Arms (1)

Reimplantation of cryoconserved bone flap

All patients who receive reimplantation of a cryoconserved autologous bone flap

Procedure: Reimplantation of cryoconserved bone flap

Interventions

Reimplantation of cryoconserved bone flap PROCEDURE

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.

Reimplantation of cryoconserved bone flap

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Inselspital Bern

Bern, 3010, Switzerland

Location

Dept. of Neurosurgery, Zurich University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Brain Edema; Bone Resorption; Osteonecrosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 19, 2014
• Study Start: January 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CH (2)