Brain EdemaSPARSNCT02320955
Swiss Prospective Autologous Bone Flap Resorption Study
An observational study of Brain Edema, run by University of Zurich at 2 sites in Switzerland.
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%. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Edema
- What is being tested?
- Reimplantation of cryoconserved bone flap
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2015to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy
Who may be able to join
- 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 join
- bone flap not fit for reimplantation
- no cryoconservation performed but other technique
- pregnancy
- patient's death
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Inselspital Bern
Bern, 3010
Dept. of Neurosurgery, Zurich University Hospital
Zurich, 8091
About this study
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.
Read the detailed 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.
- Conditions
- Brain Edema
- Being tested
- Reimplantation of cryoconserved bone flap
- Keywords
- autologous bone flap, decompressive craniectomy, malignant brain swelling, patient specific implant, bone resorption, aseptic bone necrosis
- Medical subject headings
- Brain Edema, Bone Resorption, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reimplantation of cryoconserved bone flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Reimplantation of cryoconserved bone flap | All patients who receive reimplantation of a cryoconserved autologous bone flap Receives: Procedure: Reimplantation of cryoconserved bone flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
Incidence of an indication for surgical revision
The indication for a surgical revision falls under responsibility of the treating surgeon.
Measured: 12 and 24 months after reimplantation
Death
death
Measured: 2, 12 and 24 months after reimplantation
Infections
Infections
Measured: 2, 12 and 24 months after reimplantation
Fluid collections and bleedings
subgaleal, epidural and subdural fluid collections and hematomas
Measured: 2, 12 and 24 months after reimplantation
Hydrocephalus
hydrocephalus
Measured: 2, 12 and 24 months after reimplantation
Temporal muscle atrophy
temporal muscle atrophy
Measured: 2, 12 and 24 months after reimplantation
timepoint between explantation and reimplantation
measured in months
Measured: 2, 12 and 24 months after reimplantation
patient age
in years
Measured: 2, 12 and 24 months after reimplantation
fragmentation of the bone flap
in number of pieces
Measured: 2, 12 and 24 months after reimplantation
temperature used for cryoconservation
in °C
Measured: 2, 12 and 24 months after reimplantation
pathologies leading to explantation of the bone flap (hemicraniectomy)
trauma, tumor, stroke and others
Measured: 2, 12 and 24 months after reimplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320955
- Sponsor's protocol ID
- ZH-2014-0370
- Acronym
- SPARS
- Status last verified
- May 2024
- First submitted
- 10 Dec 2014
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Prospective Autologous Bone Flap Resorption Study
- ClinicalTrials.gov ID
- NCT02320955
- Acronym / sponsor ID
- SPARS / ZH-2014-0370
- Conditions
- Brain Edema
- Keywords
- autologous bone flap, decompressive craniectomy, malignant brain swelling, patient specific implant, bone resorption, aseptic bone necrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reimplantation of cryoconserved bone flap | – | Procedure: Reimplantation of cryoconserved bone flapAll patients who receive reimplantation of a cryoconserved autologous bone flap |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing reimplantation of cryoconserved bone flaps after craniectomy
Key inclusion criteria (3 listed)
- all patients after hemicraniectomy or bifrontal craniectomy
- age 18-99 y/o
- ability to understand and sign informed consent (alternatively, legal representative may sign)
Key exclusion criteria (4 listed)
- bone flap not fit for reimplantation
- no cryoconservation performed but other technique
- pregnancy
- patient's death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reimplantation of cryoconserved bone flapA 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. | Procedure or surgery | Reimplantation of cryoconserved bone flap |
Primary outcome
Incidence of a relevant bone resorption within 12 months after reimplantation
Time frame: 12 months
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
11 secondary outcomes
Incidence of an indication for surgical revision
Time frame: 12 and 24 months after reimplantation
Death
Time frame: 2, 12 and 24 months after reimplantation
Infections
Time frame: 2, 12 and 24 months after reimplantation
Fluid collections and bleedings
Time frame: 2, 12 and 24 months after reimplantation
Hydrocephalus
Time frame: 2, 12 and 24 months after reimplantation
Temporal muscle atrophy
Time frame: 2, 12 and 24 months after reimplantation
timepoint between explantation and reimplantation
Time frame: 2, 12 and 24 months after reimplantation
patient age
Time frame: 2, 12 and 24 months after reimplantation
fragmentation of the bone flap
Time frame: 2, 12 and 24 months after reimplantation
temperature used for cryoconservation
Time frame: 2, 12 and 24 months after reimplantation
pathologies leading to explantation of the bone flap (hemicraniectomy)
Time frame: 2, 12 and 24 months after reimplantation
Results and safety
The study was stopped early (reason given: Interim analysis confirmed too high rate of bone flap resorption. Continuation of the study was deemed unethical. Available data allow evaluation with sufficient power.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Edema, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis confirmed too high rate of bone flap resorption. Continuation of the study was deemed unethical. Available data allow evaluation with sufficient power.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a relevant bone resorption within 12 months after reimplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.