A space-expanding skull cap replacement in relieving unilateral removal of the skull cap in the context of stroke treatment – a randomized controlled multicenter study
Summary description of the study
In this study, we investigate whether an implant, individually crafted for each patient, placed directly after the removal of the skull bone represents an alternative:
The implant provides slightly more underlying space compared to the original skull bone, allowing the affected hemisphere of the brain to swell. Thus, it can be placed immediately after the removal of the original skull bone and offers immediate protection of the underlying brain tissue – which means no second operation is required.
- Group 1 (experimental group) will be treated with the new surgical method: In the first and only operation, immediately following the removal of the skull cap above the affected hemisphere, the individually shaped, space-expanding skull cap implant will be inserted.
- Group 2 (control group) receives the standard treatment consisting of the surgical removal of the skull cap above the affected hemisphere, as well as the insertion of either the original skull bone or a matching implant in a second operation after the swelling of the affected brain part has subsided.
(BASEC)
Intervention under investigation
In this study, we investigate whether an implant, individually crafted for each patient, placed directly after the removal of the skull bone represents an alternative:
The implant provides slightly more underlying space compared to the original skull bone, allowing the affected hemisphere of the brain to swell. Thus, it can be placed immediately after the removal of the original skull bone and offers immediate protection of the underlying brain tissue – which means no second operation is required.
(BASEC)
Disease under investigation
Stroke
(BASEC)
- Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging – meeting the European guidelines for decompressive hemicraniectomy (DCE) in stroke
- Age: ≥ 18 and < 70 years
- Consent from the patient or a legal representative
(BASEC)
Exclusion criteria
- Hyperacute need for DCE due to rapid neurological decline
- Contraindications for the use of polymethylmethacrylate (PMMA), e.g., known hypersensitivity, allergy
- Known gentamicin allergy
- Pregnancy and active breastfeeding
- Patients with a history of DCE and/or CP
- Active lung or skull infection
- Known drug-independent coagulopathy
(BASEC)
Trial sites
Aarau, Basel, Lugano, Luzern, St. Gallen
(BASEC)
Sponsor
Prof. Dr. med. Philippe Schucht Insel Gruppe AG
(BASEC)
Contact
Contact Person Switzerland
Philippe Schucht
+41316640221
space@clutterinsel.chInsel Gruppe AG Inselspital, Universitätsspital Bern Universitätsklinik für Neurochirurgie
(BASEC)
General Information
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@insel.ch(ICTRP)
General Information
Inselspital Bern, Department of Neurosurgery
+41316322409
cedric.kissling@insel.ch(ICTRP)
General Information
Inselspital Bern, Department of Neurosurgery
+41316322409
philippe.schucht@insel.ch(ICTRP)
Scientific Information
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@insel.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
09.04.2025
(BASEC)
ICTRP Trial ID
NCT06638385 (ICTRP)
Official title (approved by ethics committee)
A space-expanding shield in decompressive hemicraniectomy for stroke – a randomized-controlled multicenter phase III trial (BASEC)
Academic title
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial (ICTRP)
Public title
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke (ICTRP)
Disease under investigation
Stroke
(ICTRP)
Intervention under investigation
Procedure: DCE + SPACE SHIELDProcedure: DCE + CP
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke
- = 18 and < 70 years of age
- Availability of consent from a next of kin and from the patient represented by an independent physician
Exclusion Criteria:
- Hyperacute need for DCE due to rapid neurological decline
- Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy
- Known gentamicin allergy
- Pregnancy and active breast-feeding
- Patients with a former history of DCE and/or CP
- Active pulmonary or cranial infection
- Known coagulopathy independent of medication
(ICTRP)
not available
Primary and secondary end points
modified Ranking Scale (mRS) score at 6 months
(ICTRP)
Number of further surgical interventions for ICP control;Occurrence of Hydrocephalus;Number of Infections;Wound healing difficulties;Syndrome of the trephined;Overall survival at 6 months;Cosmetic satisfaction at 6 months;Quality of life score: EQ-5D-5L
(ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Schucht Philippe, MD;C?dric Kissling, MD, cedric.kissling@insel.ch, +41316322409, Inselspital Bern, Department of Neurosurgery, (ICTRP)
Secondary trial IDs
SPACE SHIELD (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06638385 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available