Cranioplasty after 'decompressive' craniectomy- Registry -German Cranial Reconstruction Registry (GCRR)

Recruiting

Conditions: osteolytic or bone-destructing tumours of the skull
I63
S06
I62
I60
I61
G08
I67
Cerebral infarction
Intracranial injury

Registration Number: DRKS00007931

Lead Sponsor: Konsortium des GCRRStellvert. Prof. Dr. Oliver SakowitzKlinik für NeurochirurgieKlinikum Ludwigsburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

1. Patients with a clinical condition that requires temporary removal of the cranial bone (decompressive craniectomy, DC)
•Space-occupying cerebral infarction
•Traumatic Brain Injury
•Subarachnoid haemorrhage
•Intracranial haemorrhage
•Sinus venous thrombosis
•Space-occupying cerebral infections

2. Patients after DC which now require surgical cranioplasty (CP)

3. Patients with osteolytic or bone-destructing tumours of the skull

4. Age of (legal) majority

Exclusion Criteria

1. Patients in a clinical condition that requires permanent removal of the cranial bone

2. Patients in palliative care

3. Patients with craniofacial malformations (e.g. craniosynostosis)

4. Patients that require skull base reconstruction

5. Patients after suboccipital DC

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Neurological status (GOS, mRs) before and after 1st and 2nd surgery and at time of re-presentation<br><br>2) Overall mortality: death within a period of 3 months ± 14 d after cranioplasty intervention<br><br>3) Surgical revision within a period of 3 months ± 14 d after cranioplasty intervention<br>

Secondary Outcome Measures

Name	Time	Method
1) Patient satisfaction after cranioplasty surgery<br><br>2) Time to bone flap re-implantation (cranioplasty)<br><br>3.) Rate of surgery-related complications of both procedures (craniectomy and cranioplasty) detected up to 30 days after surgery<br><br>4) Quality indicators of surgery<br>