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Interim analysis confirmed too high rate of bone flap resorption. Continuation of the study was deemed unethical. Available data allow evaluation with sufficient power.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reimplantation of cryoconserved bone flap | All patients who receive reimplantation of a cryoconserved autologous bone flap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Death | death |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Bern | 3010 | Switzerland | |||
| Dept. of Neurosurgery, Zurich University Hospital |
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| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D001862 | Bone Resorption |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001847 | Bone Diseases |
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|
| 2, 12 and 24 months after reimplantation |
| Infections | Infections | 2, 12 and 24 months after reimplantation |
| Fluid collections and bleedings | subgaleal, epidural and subdural fluid collections and hematomas | 2, 12 and 24 months after reimplantation |
| Hydrocephalus | hydrocephalus | 2, 12 and 24 months after reimplantation |
| Temporal muscle atrophy | temporal muscle atrophy | 2, 12 and 24 months after reimplantation |
| timepoint between explantation and reimplantation | measured in months | 2, 12 and 24 months after reimplantation |
| patient age | in years | 2, 12 and 24 months after reimplantation |
| fragmentation of the bone flap | in number of pieces | 2, 12 and 24 months after reimplantation |
| temperature used for cryoconservation | in °C | 2, 12 and 24 months after reimplantation |
| pathologies leading to explantation of the bone flap (hemicraniectomy) | trauma, tumor, stroke and others | 2, 12 and 24 months after reimplantation |
| Zurich |
| 8091 |
| Switzerland |
| D009140 |
| Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |